I will operate from the same office in Raleigh, North Carolina, though please note the change in my email address (chodges@clayhodgeslaw.com) and phone number (919.830.5602).

My new JUSTIA website (www.clayhodgeslaw.com) should launch in the next few weeks, so look out for it. Thank you!

Clay Hodges
Hodges Law, PLLC
1620 Hillsborough Street, Suite 200
Raleigh, NC 27605
919.830.5602 (office)
919.830.4198 (mobile)
chodges@clayhodgeslaw.com
www.clayhodgeslaw.com
www.northcarolinaproductliabilitylawyer.com

My experience with Attorney Clay Hodges: background, our interaction, case outcome and my assessment 

1. Background

Having suffered from increasing discomfort in my left hip during a Swiss sabbatical from my teaching position at [an American university], I sought medical attention at a Swiss orthopedic clinic in September 2011. This led in short order (on 28 Sept. 2011) to a minimally invasive [hip] surgery by the resident specialist. The intervention was successful and the recovery uneventful – yet, alas, not long lasting. In the summer of 2017, and back in the United States, I started experiencing rapidly worsening left-hip pain that led me to consult with Dr. Roshan P. Shah (Columbia Medical Center). He advised for immediate revision surgery involving now both femoral head and acetabulum (i.e. a full classical hip replacement), since my 2011 Zurich [hip implant] had become completely dislocated. The revision surgery by Dr. Shah took place on 22 Sept. 2017, with recovery speedy, yet now happily long lasting (as of 16 November 2025).

2. Interaction with Attorney Clay Hodges

My initial attempt to seek legal redress in the United States for damages I (as a US legal resident) had suffered in consequence of the botched Zurich surgery had proved unsuccessful. This until Attorney Clay Hodges appeared on the scene and, after careful scrutiny of the material and jurisdictional complexities of my case, declared himself equal to it – meaning he was willing to join a cross-state [MDL] lawsuit against [the manufacturer], triggered by the multiple implant failures that had accumulated since the inception of the implant.

This leads to my first point of observation regarding Clay: he is a man both analytical (see his punctilious examination of my case, before committing himself) and of courage (see his willingness to tread where others fear to go).

Not surprisingly this two-fold characteristic is linked to a third, revealed to me as our multiple interactions (in writing and by phone, and lasting from March 2019 to May 2024) progressed: he is a man of great patience who will persist in his efforts until all possible avenues  of argument have been mulled over.

3. Outcome and assessment

Though the adjudicated payout to our case (fairly divided by Clay between himself and me) turned out to be modest, at each point in the process I felt I was interacting with a man of great intelligence and unshakable principle, equal to the best of my university colleagues.

[Former Client]
November 16, 2025

Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.

Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper Fracture Risks

Just to make things clear, practically all medical treatments come with some risks. So the question isn’t about whether there’s a risk, but the level of risk and whether a patient is properly told those risks so they can make an informed decision.

That being said, the primary issue here isn’t that there’s a bone fracture risk if you receive the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (Zimmer CPT Hip System). This is because most artificial hips have some risk of the thigh bone breaking after the surgery. The primary issue is instead whether you’re properly told about the risk of fracturing your femur should you receive this particular artificial hip, and whether this particular artificial hip carries a heightened risk of bone fracture.

The FDA cites a UK study that found that the Zimmer CPT Hip System had a risk of thigh bone fracture that was roughly 1.4%. This doesn’t sound like much, but it’s almost double the fracture rates of comparable artificial hip products. These other artificial hips had a fracture risk that ranged between 0.6% and 1.0%.

Based on this information, Zimmer Biomet initiated a voluntary recall of the Zimmer CPT Hip System to provide updated instructions that would include the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.

How Do I Know if I Received an Affected Artificial Hip from Zimmer Biomet?

The best way is to ask your doctor or other health care professional. If you’re curious about the specific models, you can find an affected product list in the FDA’s safety communication or on Zimmer Biomet’s website (it’ll be on Attachment 2).

What Should I Do If I Received an Affected Artificial Hip?

If you don’t have any unexpected problems walking, or pain around your hip, then you’re probably fine as long as you maintain the follow-up schedule with your doctor. The FDA doesn’t recommend surgery to remove the artificial hip if you aren’t experiencing any problems with it. However, it’s still a good idea to talk to your doctor to know if you have an affected device and confirm that there’s nothing additional you need to do or avoid doing.

If you’re having problems with your Zimmer CPT Hip System, then you should contact your doctor as soon as you can. They can review your situation and recommend your next course of action. You may also want to report your issue to MedWatch, which is administered by the FDA.

If you received a hip replacement surgery that used the Zimmer CPT Hip System and aren’t having any issues with it, that’s good news. But if you’re in pain, have trouble walking, or suffered a broken femur where the artificial hip was installed, legal action might be a possibility. If you want to learn more, call me at (919) 830-5602 or contact me online. In the meantime, you can talk to your doctor if you have any questions or concerns. Good luck.

Artificial hips offer many patients the opportunity to live active and full lives, but sometimes they don’t always work as intended. Thankfully, these are relatively rare situations. Unfortunately, if it’s your artificial hip that fails, there’s not much comfort in knowing the artificial hips in most other patients work as designed. Because an artificial hip failure can be such a serious problem, the U.S. Food and Drug Administration (FDA) takes steps to ensure artificial hip medical devices receive adequate review and scrutiny before being approved for use in patients. One such step is to confirm that if a company modifies an already approved product, those changes also receive appropriate FDA approval and oversight. Apparently, Synovo Production, Inc. (Synovo) failed to obtain these necessary FDA approvals after making changes to one of Synovo’s hip replacement products. Let’s take a look at what products are affected and what action the FDA has taken.

Affected Medical Devices

Synovo makes the Total Hip System (also known as the Total Hip Replacement System and the Preserve and Endotec BP), which the FDA cleared for medical use. However, the FDA claims that Synovo has made significant modifications to the following three components of this system: Femoral Resurfacing Cup, Acetabular Fixation Cup and Acetabular Bearing. Some of these components are also stand-alone products.

Because the FDA has not reviewed these modifications to ensure they’re safe and effective, the FDA issued a Safety Communication urging health care providers to stop using any of the three non-cleared components of the Synovo Total Hip System.

Potential Problems with the Synovo Total Hip System

Despite the FDA issuing this Safety Communication, there might not be anything wrong with the Total Hip System. Is it possible that the changes might actually make the product better? Maybe, maybe not. That being said, what changes were made?

The FDA’s Safety Communication doesn’t go into detail about what modifications Synovo made, but references a Warning Letter from March 2023 that discusses, among other things, Synovo’s changes to the Femoral Resurfacing Cup component.

Specifically, the letter outlined how the FDA cleared the Femoral Resurfacing Cup for use with cement to help attach it to the bone. However, the FDA notes that Synovo made changes to the product so that it received a different coating that would allow it to be attached to the bone without cement.

Attaching a hip replacement part to bone without cement may have some advantages, although this is apparently up for debate. Assuming for a moment that Synovo’s change to a cement-less hip implant is an improvement, they’d still need the FDA to confirm this is the case. After all, one of the reasons the FDA was created was in response to companies selling food and medical products that, at best, did not meet the marketing claims and at worst, harmed the consumer.

This isn’t to say Synovo is marketing and selling an unsafe product, but until the FDA can review the modification to the Femoral Resurfacing Cup and clear it as safe and effective, consumers and health care providers need to take notice.

What Patients Need to Do

The FDA recommends that patients who received any of the affected devices after 2019 should contact their health care provider if they experience problems with their hip implant. This includes:

• New or worsening pain
• Loosening of the hip
• Grinding or other noises coming from the hip
• Inability to put weight on the hip with the implant
• Any weakness in the hip or knee on the same side of the implant

If patients have no problems with the affected devices, the FDA doesn’t recommend surgery to remove the device. In other words, the FDA is suggesting a wait-and-see approach. However, the FDA asks patients with issues with their implants to notify the FDA through its MedWatch Voluntary Reporting Program.

FDA Recommendations for Health Care Professionals

The FDA asks that health care providers do several things, but the most notable include not buying or implanting the affected devices. These health care providers should also remove any affected products from their inventory. Finally, health care professionals should closely monitor their patients who have received the Total Hip System or any individual component affected by the Safety Communication.

If you received Synovo’s Total Hip System or one of its components after 2019, there’s no need for alarm just yet unless you’re having problems with your hip. Based on the information so far, if Synovo did anything wrong, it was not getting the necessary approval from the FDA for the changes to the components. But in an abundance of caution, pay close attention to your hip and discuss any concerns you have with your health care provider. Most likely you’ll be fine, but in case you aren’t, you want to be prepared.

For a while now, Stryker has had issues with some of its hip replacement artificial implants. One troublesome type in particular has been the LFIT V40 series. Specifically, in some of these Stryker hips corrosion forms where the femoral head connects with the femoral stem. This would often lead to taper lock failure, or a compromised joint that would loosen and cause metallosis.

This issue helped lead to a recall in 2016 and an expanded recall in 2018. One of the reasons for the 2018 recall was a higher-than-expected number of reports of the femoral head disassociating (disconnecting) from the femoral stem.

What Is Artificial Hip Disassociation?

Also referred to as “dissociation,” disassociation describes situations where the femoral head (the round, ball-like part of the hip implant) actually breaks away from the stem of the hip implant. The image at right helps illustrate what these parts do and roughly where the dissociation would occur.

What Causes the Stryker LFIT V40 Dissociation Failures?

The main reason for dissociation in LFIT V40 artificial hips is corrosion where the femoral head joins the femoral stem. This usually starts slow and goes unnoticed by the patient for many months and even years. Over time, the corrosion gets worse and likely causes metallosis. Once enough time passes, the corrosion gets so bad that the head and stem joint break apart or disconnect leading to a catastrophic failure of the hip implant.

What Causes the Corrosion?

The corrosion could be caused by excessive friction between the metal components. Ideally, when the femoral head is attached to the femoral stem, it is a perfect joint, with no movement between the two parts. Unfortunately, the Stryker LFIT V40 components often wouldn’t be properly connected. This could lead to micromotion, or a very small amount of “wiggling” between the parts. Too much movement or grinding can cause the neck to grind down (sometimes referred to as “penciling”), where the neck grinds away to a sharpened point, like a pencil. Ultimately, this could result in corrosive wear and create a dissociation failure.

How Can I Tell if My Hip Replacement Has Disassociated?

If your artificial hip implant disassociates, you’ll most likely know something is very wrong with your hip. You will likely endure one or more of the following symptoms:

• Pain and/or inflammation (the pain is often significant).
• Joint instability.
• Metallosis.
• Reduced mobility (even inability to walk).
• One leg becoming longer or shorter.
• Broken bones in areas surrounding the joint.

What Do I Need to Do If My Stryker Hip Implant Disassociates?

You’ll almost certainly need hip revision surgery (most likely, immediately). Because the corrosion leading to dissociation will be severe, this surgery will likely be extensive, requiring not just the femoral head to be replaced, but also the femoral stem. The removal of the femoral stem is a big deal because it will probably be very well-established in your femoral bone. The femoral stem can be removed, but it won’t be a pleasant experience.

I’m Feeling Fine Right Now, So Now What?

The first thing you can do is talk to your doctor to confirm if you received the affected Stryker LFIT V40 hip components. If you did, you’ll need to discuss the medical benefits of removing the V40 femoral head. If you’re lucky, only the head will need to be replaced and the femoral stem can be left alone. While this still requires revision surgery, it’s a far less complex or involved procedure. As always, rely on the advice of a trusted orthopedic surgeon for these medical decisions.

To learn more about potential issues with your Stryker LFIT V40 hip implant and what legal options you may have available, you can contact my office or call me at (919) 830-5602

Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, artificial hips, particularly “metal-on-metal” hips, have “failed” at a rate much higher than previous artificial hip systems, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body. As long as the metals held up, all would be well. But it turned out that this intense pressure and movement often caused the metals to grind and deteriorate, and too often releasing metal particles into the surrounding tissue and into the bloodstream. In other artificial hip failures, such as with the Stryker LFIT v40, femoral heads can malfunction due to a failure in the taper lock. The taper lock is the part of the hip prosthesis that connects the femoral head to the stem. This can cause the neck on the femoral stem to grind down (sometimes referred to as “penciling”) and can even lead to a full disassociation (more on that below).

In still other artificial hip failures, the plastic liner (between the cup and ball) deteriorates and causes the total artificial hip system to fail. Polyethylene liners are very important in an artificial hip because over the years, it will serve as a buffer between the metal cup and also the metal femoral head or ball, so it can protect against excessive grinding of the hip components. But the studies have shown that Exactech hip plastic liners have been breaking down and showing signs of premature wear.

Please note that with any hip replacement surgery, there will be a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the hundreds of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

Let’s start with the basics:

What Is an Artificial Hip Failure?

Artificial hips fail in several ways:

1. Pain. This would be pain that lingers after the period of rehabilitation, or which arises months or years after the implant surgery. There is no marker for the precise amount of pain necessary to define a failure. If you are in pain, you need to assume that something is wrong and you need to schedule an examination.
2. Swelling. The area around your hip replacement should not swell after the period of surgery and rehab is past. Swelling is a sign of a problem.
3. Metallosis. This is the build up of metal levels in the blood and/or in body tissue. When a metal-on-metal artificial hip cup and ball grind together, tiny shavings can be released into the body, elevating metal levels. A simple blood test can identify metallosis.
4. Loosening components. This is when a component like the acetabular cup has become loose and shifted or moved. It can hurt (see #1).
5. Disassociation. In some cases, the femoral head and stem actually separate or break apart. In these cases, the hip and the leg are no longer connected. This can be caused by (for example) corrosion in the V40 femoral heads.
6. Inflammation of tissue. This is where the hip area becomes swollen, warm, red, and often painful, as a reaction to the hip failure and/or as a result of infection.
7. Pseudotumor. This is abnormal tissue growth that occurs as a reaction to metal particles being released near the site of the hip replacement. A pseudotumor is noncancerous. Pseudotumor does not always cause pain or other noticeable symptoms.
8. Sounds. Other the years, several clients have reported that their hip has begun to make ominous sounds, such as grinding, whistling, popping, or thumping. Your artificial hip should not make noises.

Understand that with most hip failures, several of these conditions may be present, not just one. You may have pain, and swelling, and loosening components. Sometimes you may have all the symptoms.

What Might Artificial Hip Failure Feel Like?

1. Pain. This is nearly always the first red flag. With artificial hip failure, there will likely be unusual pain and discomfort. As doctors like to say, “always listen to your body.” If something doesn’t feel quite right, it may not signal artificial hip failure. But it could.
2. Popping sounds. I’ve had people tell me that their failing artificial hip actually made noises. The popping sound typically comes from a component that is loose or becoming dislocated. It often occurs with pain.
3. Swelling or heat coming from the hip area. A sign of infection.
4. Uncertainty. The hip feels insecure, as if the person’s leg may “give out” while walking or standing. In other cases, the hip feels as if it is locking up on the person.
5. (Almost) nothing at all. Oddly, with some artificial hip component failures, you may not notice symptoms. This is when an artificial hip failure can be most frustrating; something is wrong, but you can’t detect anything serious. For years, one person I spoke with did not feel abnormal pain, but only some discomfort after walking for long periods on hard surfaces (like asphalt). The blood tests showed slightly elevated metal levels, but not outrageously high numbers. After several years, the pain grew incrementally, and the patient eventually chose revision surgery. The revision surgery revealed a very loose cup, dark metallic fluid, inflamed tissue around the hip, and other problems. Clearly the artificial hip components had failed, and revision surgery was necessary, even overdue. But the individual for years believed everything was “good enough.”
6. Other sensations. The human body can simply react in all kinds of ways. If the feeling is unpleasant, something may well be wrong.

Despite all this unpleasantness, there is no need to panic. Panic is not good for anyone. But I do believe you must take ownership of your medical care. If something “does not feel quite right,” schedule an appointment with your orthopedic surgeon. Ask questions. Ask for a blood test. Ask more questions. Keep a symptoms journal, which I wrote about here. Stay after it.

And call me if you have legal questions: (919) 830-5602.

No specific client information was used in writing this article. And of course, I am no doctor, and this is not medical advice.

Exactech Inc. (Exactech) is a company that makes various products to repair or replace joints in the human body. Some of Exactech’s biggest selling products have been replacement joints for hips, knees and ankles. Unfortunately, there have been some problems with certain products suffering from premature wear and other issues. This has led to some patients getting revision surgery to fix the issue and repair damage caused to the human body. Exactech has also started various product recalls involving certain knee, ankle and hip implants. I have prepared the following Exactech FAQs so you can learn more about this problem and what to do if you’re affected.

1. What Exactech Products Have Been Recalled?

The recall involves two groups of products. The first group relates to certain batches of Exactech’s Connexion GXL acetabular hip liners. The second group relates to specific ankle and knee polyethylene liners and inserts, many of which were manufactured in 2004 or later. Some of these products have been sold under the following brands:

• OPTETRAK®
• OPTETRAK Logic®
• TRULIANT®
• VANTAGE®

2. What’s Wrong with these Exactech Implants?

In regards to the Connexion GXL acetabular hip liners, it appears that they’ve suffered from unexpected, premature wear. This premature wear has potentially led to patients suffering from various problems, such as:

• Pain in or around the hip replacement area
• Osteolysis (destruction of bone tissue)
• Reduced or limited mobility of the hip

As for the knee and ankle polyethylene liners and inserts, it’s believed that they weren’t properly packaged. And because of this improper packaging, the implants might have suffered unanticipated degradation or damage before they were implanted in a patient. Potential issues with these liners and inserts include:

• Loss of bone tissue
• Creation of more-than-expected wear debris in the joint
• Cracking or fracturing of the joint

3. How Were the Knee and Ankle Polyethylene Liners Improperly Packaged?

These implants are made out of ultra-high molecular weight polyethylene (UHMWPE). This special material is widely used for joint replacements because it reacts little with the human body and has good durability.

The problem with UHMWPE is that it reacts with the oxygen in the air we breathe. When it does, the UHMWPE loses its strength. This can create a large number of wear particles around the joint.

Exactech can’t just package these liners in any container. Instead, they must place the implants in special vacuum bags, made out of ethylene vinyl alcohol (EVOH). This prevents the oxygen from the air from contacting the liners and inserts.

Exactech reported that roughly 80% of their inserts made after 2004 weren’t properly packaged. Specifically, Exactech packaged them with oxygen-resistant bags, but not bags made from EVOH.

4. If I Think I’m Affected, What Should I Do?

The first thing you should do is contact your orthopedic surgeon, even if your implant seems fine. Your doctor will likely have you come into the office to answer questions and complete a physical examination that could include X-rays. Depending on what your doctor finds, they may advise you to get corrective “revision” surgery to replace the faulty implant with a new one. Or, they may ask you to make regular follow-up visits so they can monitor the condition of your joint replacement.

Assuming you have an implant that’s part of the recall and are suffering problems, you shouldn’t have to pay for this additional surgery or related medical care. The only question is how these costs will get paid.

Exactech is attempting to resolve many of these claims through a third-party claims administrator: Broadspire. Broadspire will get information from you and make arrangements to see that you don’t have out-of-pocket costs relating to problems with your ankle, knee or hip implant. Be very careful in choosing this route, as it may not compensate you fully for all injuries and costs.

Another option is to file a lawsuit. In addition to receiving reimbursement for your current medical bills and costs, you and/or an immediate family member may also receive damages for:

• Pain and suffering
• Future medical expenses
• Lost wages
• Loss of consortium
• Loss of enjoyment

As you can see, the potential recovery from a lawsuit is more likely to fully compensate you for your financial costs, as well as the harm suffered from a faulty joint replacement product. But there’s the tradeoff of having to spend the time and money to litigate and there’s always a risk of getting nothing if you lose your case.

How do you decide what to do? You make the decision with the help of a product liability lawyer who handles defective medical product cases. And no, this doesn’t mean you have to hire the attorney you speak with. You can simply get a consultation to learn about which option might be best for you. There’s a chance there could be another option to consider based on your unique circumstances. But you won’t know until you speak with an attorney. Feel free to get in touch with me at (919) 830-5602 and I’ll see how I can help.

Note: This post is not legal advice.

Before we talk about Exactech liners and defective packaging, we need to talk about oxygen. Oxygen is necessary for human life, but it’s a fairly reactive chemical element. We don’t think of oxygen as damaging but it can be very reactive. A perfect example of how reactive oxygen can be is fire. Get most things hot enough and they’ll start to react with the oxygen in the air and oxidize rapidly. In other words, they’ll start to burn.

This reactivity many things have to oxygen is one of the major reasons why there’s a recall for Exactech’s hip, knee and ankle implants. No, they don’t catch on fire, but they may have been exposed to too much oxygen before implantation. This could lead to premature wear, damage to bones and the implant breaking while inside the body.

How did the implants come into contact with too much oxygen? It appears to be the result of faulty packaging. Let’s take a closer look at what was wrong with the packaging and why that has allegedly led to problems with the Exactech implants.

Why Can’t the Implants Get Exposed to Oxygen?

When we worry about something getting too much oxygen, we’re usually referring to a situation where someone or something gets exposed to more oxygen than is typically found in the air we breathe. In most environments, oxygen makes up 21% of the air. But in the case of Exactech’s implants, even the 21% oxygen found in the air was enough to cause problems.

Many ankle, knee and hip implants from Exactech and other manufacturers are made from ultra-high molecular weight polyethylene (UHMWPE). This is a popular material for joint replacement because it has good resistance to mechanical wear and doesn’t react much with the human body.

One reason why UHMWPE is so durable is because it has special bonds and links between its molecules. But these special bonds and links can react with oxygen. This reaction then reduces the bonds and links that give UHMWPE its strength and durability. This can lead to the material becoming much weaker and creating tiny bits of debris around the joint.

To counter this problem, artificial joint manufacturers have special methods for packaging UHMWPE implants. First, they place them in special vacuum bags that have little to no oxygen inside them. Second, they use special materials for these vacuum bags, such as ethylene vinyl alcohol (EVOH). The EVOH helps keep air from leaking through the vacuum bags and exposing the implant to oxygen.

How Was Exactech’s Packaging Defective? According to Exactech, many of its implants made from UHMWPE were not packaged with vacuum bags that contained EVOH. This meant that before the ultra-high molecular weight polyethylene implants were placed inside a patient, they were potentially exposed to oxygen, became damaged, and didn’t have the mechanical properties they should have had.

What Now?

If you think you may have received an Exactech liner implant that could have been affected by the defective packaging, contact your doctor. Your doctor can check to see how your artificial joint is performing and help you confirm if there’s a problem. Depending on what they find, they can advise you on what you should do next concerning your physical health.

If it turns out you have a defective implant due to improper packaging, then you should think about calling a lawyer to learn more about your legal options. If you know of an attorney that can help you through this process, great. If not, feel free to give me a call at (919) 830-5602 and I’ll see how I can assist.

Note: This article is not legal or medical advice. The article was written after review of news articles, company press releases, and FDA reports. Images are for illustrative purposes only.

Several years ago I wrote a blog post for my product liability website where I encouraged medical device manufacturers to put me out of business. What I meant by writing that article was to say that I would be happy as a lawyer to move on to other practice areas on the day that medical device companies properly tested their medical devices before they put them on the market, ran the appropriate clinical testing, carefully reviewed the studies that came back, monitored the patients who receive the medical devices, and didn’t misrepresent the products in their marketing and advertising materials.

And if all that occurred and product defect injuries dropped through the floor, then I would happily stop practicing product liability litigation and move on to other practice areas. Or go work at my neighborhood bookstore (Quail Ridge Books).

But I also said in that article that it’s unlikely that I would be changing my line of work any time soon, and that was six years ago. And here we are, today, and it’s still the case that there is plenty of work for me to do.

In that article, I wrote that I do not believe that all medical device companies are pursuing profit to the detriment of patients’ health and that many times the medical devices are properly tested. And often these devices are wonderful for the community and there are wonderful advancements in medicine and science. But sadly, there are too many occasions when these companies rush a product to market and end up with hundreds or even thousands of patients who were injured that didn’t have to be injured.

So today we’re going to look at a new recall of an existing product that has been implanted in thousands of people, and studies are showing that it’s causing a lot of problems. These are the plastic liner implants for Exactech companies: artificial hips, knees, and ankles. Exactech Inc. does business in the joint replacement field, and the company has produced many products over the years. Many of these products, as far as I know, have held up well.

But recently, in June of 2021, there was a recall of several different types of plastic liners that fit within normal artificial hips, artificial knee implants, and ankle replacements. They’ve been in business since 1985. Recently there have been a series of Exactech plastic liner products that have caused a great deal of trouble.

Exactech Artificial Hip Liner Recall

I think it’s best to first look at the plastic liner in artificial hip replacement surgery. For almost 20 years now, Exactech has manufactured and sold polyethylene liners for implant as part of artificial hip surgery called the Connexion GXL polyethylene liner. These Exactech hip liners are made from ultra-high-molecular-weight polyethylene (UHMWPE).

This ultra-high-molecular-weight polyethylene has shown in studies to be subject to premature wear and breaking down. The liner is the little insert that goes into the metal acetabular cup and the plastic liner sits between that metal cup in a metal or ceramic femoral head or ball.

So the polyethylene liner is very important in an artificial hip because over the years, it will serve as a buffer between that hard metal cup and also the hard femoral head or ball. And so it can protect against excessive grinding of the hip components. But as I said, the studies are showing that Exactech hip plastic liners has been breaking down and showing signs of premature wear. These liners have been on the market for maybe 18 years.

Some of those problems include destruction of bone tissue, hip pain, leg pain, back pain, limited mobility or range of motion.

What I would say to you is if you’ve had an artificial hip replacement in the last 18 years and you’re having problems now, or if you’ve had problems over the past few years, you might want to check out your surgical records and find out what exact products were placed in your body going back as far as 2004 or 2005, and just confirm that you don’t have an Exactech polyethylene liner.

If you do, you might want to do a little more research to see if you qualify for possible litigation. And certainly, if you haven’t had revision surgery, you and your doctor should decide if revisions surgery may be necessary.

You can also go to the FDA’s website and type in Exactech Connexion. You can even see what kind of serial numbers are involved, catalog numbers and maybe you can piece together for yourself if this product was implanted in your body as part of your artificial hip replacement in the last ten or fifteen years.

From 2008 to April of 2021, there were more than 89,000 GXL Connexion liners implanted worldwide. Thus, if these liners are wearing out prematurely, if they are grinding down more than they ought to and faster than they ought to then there could be a lot of people among this crowd of 89,000 people that might have some problems that arise from this product.

Exactech Knee Liner Recall

The second group of recalls related to Exactech plastic liners involved knee replacement products. These Exactech knee liners are made from UHMWPE, ultra-high-molecular-weight polyethylene. Focusing on the knee liner, this ultra-high-molecular-weight polyethylene, it’s a type of sophisticated plastic. It has to be packaged in special oxygen-resistant vacuum bags. And this is one of the key problems for the replacement liners, because the bags used were not sufficiently oxygen-resistant.

The studies have shown that the packaging lacked the secondary barrier which contained ethylene vinyl alcohol. And this ingredient is necessary to package these plastic liners for long periods of time. So what happens, without this ethylene vinyl alcohol in the barrier in the packaging, the plastic liner can be exposed to higher amounts of oxygen. This oxygen intrusion can lead to excessive oxidation of the ultra-high-molecular-weight polyethylene. Think of it essentially as the defective packaging allowed this high-level plastic to degrade over time. What occurred is that the pathway to premature wear or destruction of the plastic liner may have occurred before it ever got implanted in a person’s body as part of a joint replacement.

It was already on its way through that oxidation process of prematurely breaking down, then becoming defective, and then causing problems such as bone loss, pain, or eventually the need for the patient to get a revision surgery. So that’s what we think is going on mainly with the plastic liners for knee replacement surgeries.

Since 2004, Exactech sold as many as 140,732 liner tibial base plates for a knee replacement surgery. Some of the names that Exactech has manufactured and sold these model tibial base plates include Optetrak Classic, Optetrak Logic, Truliant, Truliant NCR, and CR slope.

There are many different sub-models of these knee liners. But they sold over 60,000 Optetrak Classic and over 60,000 Optetrak Logic. So again, if that’s a word that you can keep in your head or if you’re looking through your surgical records and you see that word jump out from the product stickers page or the nursing records or the operative report, then you may have one of these potentially defective plastic liners in your body.

Just to give you the language that Exactech sent to surgeons all across the country, they explained that “oxidation can severely degrade the mechanical properties of conventional UHMWPE.” That is the ultra-high-molecular-weight polyethylene, “which in conjunction with other surgical factors can lead to both accelerated wear debris production and bone loss, and/or component fatigue, cracking fracture, all leading to corrective surgery.” And that is an excerpt from a Dear Doctor Letter issued in February of 2022. So plainly, Exactech is (now) taking this very seriously. The FDA is taking it seriously.

There are several recalls all around these products that you need to be aware of. And if you’re listening to this podcast and probably means in the last 20 years, you had hip replacement surgery, knee joint replacement, or even ankle replacement surgery. And so, it’s always important to be educated on these recalls and these products that somehow don’t get the job done.

The studies are still ongoing but I think it’s safe to say that the packaging for a lot of these polyethylene liners from Exactech led to a lot of this premature wear and breaking down. And that’s where we are for these plastic liners.

Exactech Ankle Liners

I will touch briefly on the Exactech ankle plastic liners that you might run across for those of you who had an ankle replacement. The ankle product is a Vantage fixed bearing liner.

If you’ve had an ankle replacement, you might want to keep an eye out for the Exactech Vantage. See if that’s part of your ankle replacement system. It’s my understanding that there might be as few as 1,500 of these products out there. And I don’t know what percentage of that would be subject to recall, but it’s important to keep that in mind if that’s a surgery you’ve had in the last decade.

So, that is a quick overview of the series of recalls that Exactech company has issued for its hip, knee, and ankle joint replacement surgeries. We are focusing on plastic liners here and that is going to lead to litigation all across the country. And in fact, there have been many cases already in state and federal courts that have been filed.

And those cases are moving along, but it’s still very early in the process. I suspect there will be a multidistrict litigation (MDL) site identified for these sets of cases in the coming weeks or months. And I believe there’s going to be hundreds if not thousands of plaintiffs that join the litigation.

Now, remember, multidistrict litigation is not the same as a class-action lawsuit. All of these MDL cases stand on their own; there are individual lawsuits that you would bring if you were injured by the defective product manufactured and sold by a company like Exactech.

And the multidistrict litigation is utilized where one judge can handle pre-trial issues, discovery issues, pretrial motions, moving these large numbers of cases along, trying not to replicate discovery, or taking the same depositions over and over again.

If you as a patient believe that you might be a victim of one of these defective plastic liners in joint replacement surgery, then you can certainly call my office. You can also read articles about the Exactech liners on this site and find out a lot more information.

Finally, you are always welcome to call me ((919) 830-5602) or call someone you trust in the legal community.

Earlier I wrote about how Exactech was recalling many of its ankle, hip and knee liner implants. These recalls were based, at least in part, on several studies about how these implants could suffer from premature wear. This could then require patients to need revision surgery (surgery to repair problems from an earlier surgery) to fix the defective artificial joint.

In this blog post, I’ll take a look at some of these studies and try to explain what these studies found, what their findings mean and why they prompted Exactech to initiate these recalls.

The Materials Used in the Hip, Knee and Ankle Inserts or Liners

The Exactech recalls we are discussing relate to the material used in these implants, which is UHMWPE (ultra-high molecular weight polyethylene). Until the implant gets placed inside a patient, it must be carefully stored in oxygen-resistant packaging. This is to prevent the liners and inserts from coming into contact with too much oxygen (the air we breathe contains about 21% oxygen).

The Basis for the Ankle and Knee Liner Insert Recall

The scientific explanation concerning these recalls is complex. The primary reason for Exactech’s recall of its ankle and knee products appears to be the result of a review of patient data. Specifically, how an unusually high number of patients received revision surgery because of faster-than-expected wear of the liner implant.

Exactech has tried to figure out the exact cause of the higher failure rates. One potential cause may be the result of improper packaging of the product. As mentioned earlier, UHMWPE doesn’t like to be exposed to too much oxygen during storage. If it is, it could result in damage to the liner or insert, which could lead to premature wear once inserted in the human body.

The reason things are unclear is because the data used by Exactech is incomplete. The data doesn’t differentiate between implants that come from production batches that used improper packaging and batches that had proper packaging. To be safe, Exactech has recalled all batches that could contain improper packaging, even though some of the products being recalled might be degrading or defective.

Studies Relating to the Hip Liner Recall

When it comes to the problem with Exactech’s hip liner, what we know is that these hip implants use the same UHMWPE material. It’s not established at this point that the hip products containing this material were improperly packaged. But let’s step back for a minute to help put things into the proper context.

Before Exactech and other companies began using UHMWPE for their implant products, they used conventional polyethylene or highly cross-linked polyethylene. Highly cross-linked polyethylene seemed to work better than conventional polyethylene because it seemed to last longer in patients over the long term. But highly cross-linked polyethylene seemed more likely to suffer from cracks and fractures compared to conventional polyethylene.

Engineers and scientists went back to the drawing board and appeared to come up with the ideal material for hip, knee and ankle joint replacements: UHMWPE. This new material seemed to have the long-term wear properties of highly cross-linked polyethylene, but without the tendency to crack or fracture.

Unfortunately, there are at least three studies that found unusual rates of failure with hip replacements using UHMWPE. All of these studies are from the last few years and examined Exactech’s Connexion GXL liner, a hip implant using UHMWPE.

The first study is titled, “Early Polyethylene Failure in a Modern Total Hip Prosthesis: A Note of Caution.” It looked at individuals who received the hip implant in question during a ten year period and suffered from osteolysis (damage to bone tissue). The study identified twelve patients, nine of whom needed revision surgery.

The authors of the study didn’t identify the cause of these results. But they later speculated that if there wasn’t a problem with the product’s design, the problem could be limited to a specific production batch and be the result of a manufacturing error.

The second study is titled, “Early Failure of a Modern Cross-Linked Polyethylene Acetabular Liner.” It looked at five patients that received the Connexion GXL liner, but suffered from severe osteolysis and wear of the implant within five years of hip implant surgery.

The study did not conclusively identify the cause of the premature wear, but the authors suspected that there could have been a variation in how some of the Connexion GXL liners were produced.

The third study is the most recent and is titled, “Unexpected Wear of a Uniquely Designed Moderately Cross-Linked Polyethylene in Total Hip Arthroplasty.” The researchers examined 38 patients who received Exactech’s Connexion GXL liner. The study found higher-than-anticipated wear, with about half of the patients at risk for osteolysis.

So What Do These Studies Tell Us Exactly?

They tell us that there is likely a problem with Exactech’s ankle, hip and knee implants that use the UHMWPE. Of course, more research and data are needed to understand if the problem comes from the implant’s design or production process, or a combination of factors.

No matter what subsequent research finds, if you think you’ve received one of these joint products, you should talk to your doctor. Depending on what they tell you, if you want to look into your legal options, you should give me a call at (919) 830-5602.

This post was written from publicly available studies and news reports. Photos are for illustrative purposes only.

Many of Exactech’s joint replacement products have performed well and improved the lives of patients. But over the last fear years, Exactech has learned from multiple studies that some of its ankle, knee and hip products can suffer from premature wear or other problems. Many of these issues could result in the need for patients to undergo revision surgery to replace the device and repair any damage it may have caused to the bone and/or soft tissue.

Exactech has initiated various recalls in response to these problems. The purpose of this blog post is to provide a brief overview of which products have been affected, what’s wrong with these products and what you can do if you’ve had one implanted into your body.

Which Exactech Products Are Subject to Recall?

Currently, Exactech’s hip, ankle and knee joint replacement products are having problems. Based on the issues associated with the artificial joints, the recall has been organized into two groups.

The first group involves the knee and ankle polyethylene liners and inserts. The exact products can be found on Exactech’s website, but include products marketed under the following names:

• OPTETRAK®
• OPTETRAK Logic®
• TRULIANT®
• VANTAGE®

If your ankle or knee replacement surgery uses any of these products and it was manufactured in 2004 or later, there’s a good chance you could be affected.

The second group relates to hip polyethylene liners. The affected products are available for review on Exactech’s webpage, but most involve the Connexion GXL branded acetabular polyethylene liners.

What’s Wrong with the Exactech Knee and Ankle Liners and Inserts?

These liners are made out of ultra-high molecular weight polyethylene, or UHMWPE. This requires them to be packaged in special oxygen-resistant vacuum bags.

Unfortunately, the packaging lacked a secondary barrier containing ethylene vinyl alcohol. Without this special ingredient, the insufficient packaging allowed the insert or liner to become exposed to a higher-than-expected amount of oxygen. This could lead to excessive oxidation of the UHMWPE. This can dramatically degrade the physical integrity of the knee or ankle liner or inert. Problems that could arise after joint replacement surgery include:

• Higher-than-expected wear debris in the joint.
• Bone loss
• Fracturing or cracking of the artificial knee or ankle joint.

What’s Wrong with the Exactech Hip Liners?

Unlike the problem with Exactech’s ankle and knee products, the hip acetabular liner issue doesn’t relate to packaging. However, the hip liner is made out of the same ultra-high molecular weight polyethylene, or UHMWPE.

It’s not believed that the UHMWPE was negatively affected by excessive oxygen exposure before use. But there’s still a concern in the form of premature wear of the polyethylene liner. This has caused a variety of problems in patients, such as:

• Destruction of bone tissue (osteolysis)
• Pain
• Limited mobility or range of motion

Not all patients have been affected the same way. Most patients suffering from problems received their hip surgeries about three to six years ago. And problems with the polyethylene hip liners seem to be more common in those who are more physically active and/or received hip replacements that use larger femoral heads and thinner acetabular liners.

What You Should Do If You Think You’ve Been Affected by the Recall

The first thing you should do is contact your doctor. You should reach out to her or him even if you’re not experiencing any problems with your ankle, knee or hip replacement. Your doctor can confirm if you’ve received an Exactech artificial joint that’s been recalled. Your doctor can also properly assess your condition and help you decide what your next steps should be from a medical standpoint.

Depending on what you and your doctor find, revision surgery may be needed. You may also have legal options, including filing a lawsuit. Only after contacting an attorney can you know if you have a case against Exactech and what your potential legal remedies could be.

Exactech is also accepting claims relating to the recall. However, it’s a good idea to first talk to your doctor and have an initial consultation with a lawyer before agreeing to any claims reimbursement from Exactech. You can call me at (919) 830-5602 to discuss your potential case, or another attorney you trust. Good luck.

Clay: Over the past ten years you have seen a lot of metal-on-metal hip implants. Several years ago an attempt was made to put a metal-on-metal artificial hip together, and that was supposed to last forever, or last a whole lot longer, and it turned out that it was problematic. And I know you have had many patients who have had that [implant]. What did you see out of the metal-on-metal hip implants when they were failing?

Amy: Again, the first cardinal sign that I saw was chronic pain, an inability to weight bear normally through that joint. So even after normal hip replacement, the patient should be able to weight bear through it. It should not feel like they collapse on that hip, and so a limp that never resolves or an inability to get away from an assistive device. So, I had a patient in her 50s that could not get off a walker. She was 50. She was playing tennis five days a week before she had her hip replaced. Yes, with the metal-on-metal she suffered metallosis and she had an overt failure of that joint replacement. She was a candidate for this new [metal-on-metal implant], now widely known to be a bad device, because she was so young, active, fit, and healthy. It was supposed to last for longer. It was supposed to allow her to have more function larger range of motion, less risk of dislocation and all of those things. So as we know, that did not really work out so well.

Clay: Yes.

Amy: So the folks that had the metal-on-metal problems, metallosis was the biggest problem that ended up causing really frankly catastrophic changes in these people’s lives because the metals in the two appliances, they ground on each other and it leaks metal, particularly cobalt. That was a big metal that became known to become systemic and to basically create toxicity in the tissue surrounding the joint.

The metal would basically eat or erode away musculature bone, osteolysis was one of the biggest problems where it caused bone to basically just break down and be eroded away. I was actually in the operating room and saw some revision of a hip that experienced metallosis. And in the revision the musculature that was away from the hip, so when you go in to do a hip replacement, obviously, it is an open field and so you can see all of the connective tissue all the layers of musculature of the capsule of the joint this particular patient.

The capsule of the joint was this dingy gray looking color. You knew inherently. You did not have to know anything about science or medicine to know that it is probably not supposed to look like that. And what is astounding was how far away that metal leached into the musculature and so because it is toxic, because it is corrosive, that tissue had to be ripped [out]. It had to be excised. So some people lost part of their musculature and some of it was very important musculature around the hip in regards to stability and mobility restoration in the hip.

So, because the metallosis affected the bone, revision surgeries then became a bit tricky because, so when these folks went in for their first hip replacement, they had this beautiful landscape. They had a bad hip. They had a bad articular surface, but the landscape around it, and by that I mean the bony components that are going to hold that new joint, they were healthy. Otherwise, they would not have been a candidate for a hip replacement. Okay, so they had a healthy landscape to put those two new pieces in the socket. The acetabulum and the femoral head. So, once the metal started breaking down some of the bone, now all of a sudden you have got a landscape. It is not all that great in regards to the how to receive this new joint. So these folks had significantly limited post-op. They had to protect those joints dramatically for long periods of time so that could allow this bone that had really taken a hit to grow into the new prosthesis, which is how you heal a hip replacement. So, it made the post-operative course significantly different than a primary hip replacement where you walk immediately after surgery. I mean, I have seen patients ten days post-op, that are already on a cane and have a pretty decent gait. So–

Clay: Well, that is kind of horrifying, a revision is one thing but a revision when the whole landscape of the hip and the thigh and the leg and all that area is severely compromised. It makes the revision surgery less likely to be successful. So, that gets me to this question. I know you have seen it quite a bit. Tell me what the rehab might look like and I know it is different for all people. But what might the rehab look like for a person who has to get multiple surgeries on the same hip? I know it is compromising. How would it be compromised?

Amy: So that same patient when they had the first hip put in, when as soon as they started physical therapy within 24 hours of their surgery. They would be putting weight if they are usually what is called “weight bear,” as tolerated. So basically, we want you putting weight through that new joint. So as much weight as you feel like you can safely place through that leg using a walker, because everybody starts out on a walker, their weight bear is tolerated.

So, that is in the primary hip replacement that is uncomplicated. In just a plain revision, they can be non-weight-bearing for four to six weeks. So just right out of the gait. They are not putting any weight at all through it for four to six weeks. In the cases where these folks had really substantial metallosis, sometimes that non-weight-bearing was extended 8 to 12 weeks. And now you are talking about being completely non-weight bearing which, by the way, is very difficult to do.

Clay: Yes.

Amy: It is really hard if you think about how difficult that is for your upper body and for your contralateral side, for that other leg to be completely off that leg for anywhere from six to twelve weeks. And the reasoning is because that landscape they wanted, the surgeons wanted, every opportunity for that bone to accept that new part for it to heal because bone is live. So it grows into the prosthesis, into the implanted part of the prosthesis.

So they want that bone grow in because over the course of time, that is where the fixation actually lives. That prosthesis becomes incorporated into the bone itself. It great becomes part of that bone. So that is one of the biggest things that occurs postoperatively in those revisions. And so, then you have to think about everything that happens with that revision. So let us say your non-weight-bearing for six weeks, well, if you took your very healthy hip and you got off of your leg for six weeks, you would be astounded at how much strength you lose.

Clay: All right.

Amy: It is astounding through the entire extremity. And so there is profound strength loss.

Clay: So what is your medical opinion about the likelihood that a follow-up surgery or revision surgery will be successful? I mean does the chance for success just drop through the floor once there has been a failure of an artificial hip? Such that you say to yourself “My goodness. This person is going to really struggle,” or is it case by case? And in a lot of cases revision surgery can be fine for a patient.

Amy: I think that any joint replacement hips included the first one that you get because of that pristine landscape is the best chance you have to have a great outcome. Every time that that surgeon has to go back in, the opportunity for a great success go down.

Clay: Right.

Amy: And that is just the way it is. But the problem is that, like for the folks that had these metal-on-metal joints, they did not have an option. I mean, they were in such profound pain. The debility they had to get that hip taken out. And they just basically had to deal with whatever that metal did to the surrounding tissue and they had to try to protect the healing tissue the best they could and understand that their outcomes were going to be less than perfect.

Clay: Right.

Amy: Not what they had planned. Not what my fifty year old patient who had every plan of going back to the tennis court because that is why she had a hip replacement, because we know that she can go back to doubles tennis.

Clay: Right. Did not happen.

Amy: No, matter of fact, she was just happy frankly at the end of the day after a exhausting very very physically and emotionally challenging rehab process. She is happy to be able to walk and to not feel like she has a nail being driven through her hip every time she way bears.

Clay: I see.

Amy: So her measure of success changed dramatically after her revision.

Clay: I bet. Well, let me try to end on a slightly more upbeat note. Have you seen better outcomes in the last few years since we have learned what we have learned about metal-on-metal hips? And have there been fewer revision surgeries among your patient population?

Amy: There absolutely have been. As matter of fact, it probably in the last four years, I have had quite a few patients that have not even needed to do anything with me postoperatively. They were strong enough, healthy enough, and had prepared themselves for their surgery enough that they did not even need to do PT. Basically, they just had to protect their hip for a little bit, gradually get their weight back on it. And so, there is no question that the hip surgery that is going on right now, the total hip replacement surgeries, and I am seeing are phenomenally successful. If we look at the whole spectrum of success, I think the last that American Academy of Orthopedic Surgeons was a 95% success rate. I mean that is pretty high success rate for a very dramatically large spectrum of people [aged] 11 to the 90s. So, you know, it inherently has great outcomes. It is just when the outcomes are not great, it is bad.

Clay: Yes. I have seen it in my work as well. This is what I wanted to talk to you about today. This has been fantastic.

Amy: Well, I hope I answered your questions adequately, and I am happy to talk with you.

Clay: Well, thank you so much and who knows, if I have another subject to discuss, maybe we can do this again one day.

Amy: I would love to do that, Clay.

Clay: Well, thank you Amy. I really appreciate your time.

Amy: My pleasure. Have a great night.

Clay: You too.

Note: You can also listen to this conversation with Amy Dougherty in my podcast. If you want to talk about a possible defective artificial hip case, call me: (919) 830-5602.

Safe and Unsafe Activities and Sports Clay: What are some sports that you would discourage [after hip replacement surgery]? I know there is a huge range of results and people who are dealing with certain physical issues. But are there any sports you’ve seen as a physical therapist that you say “Do not do this after hip replacement surgery?”

Amy: Oh absolutely and just to clarify my youngest total hip replacement patient was eleven. This child had a very aggressive cancerous tumor that invaded her hip, and so she had what is called a Ewing sarcoma. And so, they ended up having to take the hip give her a new hip, and her big goal was she wanted to be able to drive a car. I mean that is really important. So, she was eleven when the process started and she did not drive a car. So, and I have treated, I actually had a ninety five year old who had, so the spectrum of age is even greater than thirty five to eighty two.

Clay: Sure.

Amy: But there are absolutely some things that are just absolute no’s. And most of them are things that make sense, like contact sports. So things like football, rugby, soccer. There was a great little study that came out, I think it was in 2011. Anyway, it basically looked at all of these different sports and it reviewed all of the literature and it was looking at what are the things that we know are absolute no-no’s.

Amy: And we know this because the literature shows us that these people had high rates of failure in their hips. Oh and by the way, this recommendation basically it was a systematic review and when they made these recommendations, they qualify them into three categories. So, the first category was not recommended after a total hip and so the contact sports hockey, football, soccer, rugby, any long distance running. And that just make sense.

Amy: A lot of people take a toll on their hips by doing a lot of running, and that does not mean that running causes hip arthritic changes that create a total hip that necessitated total hip replacements. Do not misunderstand that, but there is a wear and tear process that goes on with people that are running hundreds of miles a month. So, singles tennis, it gets down to just the numbers of steps that go through that new part; racquetball, squash, snowboarding, and that is because of the risk of dislocation for snowboarding.

Amy: High impact aerobics, fast pitch baseball and softball, because of sliding and contact. The kicking that is involved in many of the martial arts is not recommended. Water skiing and handball. So those are the things that under the category of not recommended. And I will tell people flat-out “Listen, you had a bad hip, you have gone through this process to get a good hip. Be nice to it, protect it.” I understand that you are putting yourself at great risk of early failure or other complications, like dislocation and things like that that necessitate revision. So that is in the not recommended category, and then they created this other category that they call “recommended with experience.” And this actually, again, makes sense. Cross-country skiing and downhill skiing, that is not the time to start learning to ski after you have had a new joint. Now, if you have been a lifelong skier and you have the experience, by all means do it. Make a choices. Mogul fields are probably not a great idea.

Clay: Right.

Amy: If you can cross country ski downhill ski safely. Doubles tennis again, not the time to take up tennis if you have never played in your whole life and you finally have a new hip. Now is not the time to take that up. But if you have been an avid tennis player, so I would absolutely and I have a lot of patients that have gone back and my brother included in that category who has gone back onto the tennis court with a joint replacement.

Amy: Ice skating not hockey. But ice skating is okay if you have experience doing that, things like rollerblading same thing kind of inline skating and Pilates. So those are things that we recommend that are qualified as recommended with experience. I will also add now, this study came out, this recommendation, systematic review was published in 2011. Surfing goes into that category. So if you are a surfer, absolutely if you have experience on a board, you are absolutely prepared to get back on that board after a hip replacement. Not the time to start introducing that into your sport life.

Clay: See it makes sense that if you have got experience you can keep yourself from potential injury.

Amy: Precisely, and then the list of things that are highly recommended because again, you know when you are in the rehab world what you realize that people go through the surgeries for they do it purposefully and it is usually to return to some type of function or activity, that they are arthritic or their painful joint would not let them take part in, so golfing, swimming, doubles tennis, stair-climbing, so like the elliptical walking, speed walking hiking, stationary biking, bowling, these are all things that are highly recommended. We want you to go back to these things because they are going to be healthy for you. They are going to sustain the strength in the mobility that you have recovered at that new joint. But they are also going to be safe for it. They are not going to put your new joint at risk.

Clay: I see. Well that gets to the point that staying active is absolutely essential. That you do not want to pick up downhill skiing necessarily, but you absolutely after hip surgery want to be active in something. And so, it is good to get going.

Amy: I am a physical therapist. I think we all should move. We should move, that is what our bodies are designed to do. They are not designed to sit and be sedentary. They are designed to move us through space.

What It Feels Like When Artificial Hips Fail Clay: Well, that is right. So, I have known you for quite a while and I know you have had patients that have had hip replacement surgeries fail. Can you tell me what symptoms you notice when a patient might come in and say “I had surgery a year and a half ago or two and a half years ago and something feels different. Something sounds different”? Talk about artificial hip failure.

Amy: Sure. Absolutely, well probably, so there are different reasons that hips can fail. But the number one thing that people complain of is pain that is out of context to what they should be experiencing at that point during the rehab process or during the recovery process. So obviously, you have had a joint replacement. We expect it to be swollen. We expect it to hurt. We expect it to be sluggish. It is not going to move well.

Amy: So, there is an expectation of some pain following the surgery but there is a point where that pain should be resolving. And it should be integrating and it usually lives as the tissue is healing. So the bony tissue is healing, where the new hip implant, the new appliance, has been mated with the bony surfaces, so that healing takes place and then the soft tissue around that joint is healing and you are becoming more mobile. So, that pain should frankly just gradually decrease until it is gone.

Amy: When someone’s hip has failed, that does not happen. The other thing that is really interesting, or I think that is telling, is that typically these patients have pain even when they are not moving, and a significant amount of pain. Now again, initially immediately after the surgery, it is normal to have night pain that makes it tough to be comfortable. But after a couple of weeks after a hip replacement, you should be able to sleep for periods of time. Many times people have so much pain that they cannot sleep. Like, it keeps them awake.

Amy: Nocturnal pain is always something that worries me because at the end of the day, we are kind of hardwired to get rest but pain prohibits that. To me, that is, I am always going to look very carefully at this patient because that should be something that initially pain management should be taken care of, so medications, icing, making sure that your activity levels are appropriate for that stage of your recovery.

Amy: If all of those things are in line, and this person is still telling me, “I slept an hour.” I do not like that. Immediately that is a red flag to me that I need to take a really close look at what is going on with this patient. So, pain is out of context to what the pain level should be at that point. Pain that is occurring without moving. So, it is not mechanically driven pain.

Amy: Any type of mechanical clicking, grinding, and these are things that people will sometimes report, you know, it clicks, it grinds, it snaps. Some people have reported they can actually feel it move. So those are things that tell me that something organically is not healthy in that hip, in that newly replaced hip.

Clay: Let me follow up on that. Is it your medical view that a successful hip replacement surgery should end with no pain at all after the rehab is over, and after the recovery is over that there should be little to no pain?

Amy: Absolutely, and when that does not happen, if let us say, and I have seen this before, I have had people show up a year after hip replacement and they say, “You know my hip still bothers me.” And upon assessment, there might be a really good reason. You are profoundly weak, you did not build the strength around this joint to give it stability. So your pain is actually not in the actual hip itself, it is in the pelvis because of the forces that are going through hip joint that and the musculature of the strength is not adequate to control those forces.

Amy: So, sometimes there is a reason that someone has got pain a year later. But in the absence of something like that going on, no, you should not have pain. That is the whole reason that you have this new hip put in. So if you are continuing to have pain, I tell my joint replacement patients that it takes a year to recover from these big surgeries. But that is a pretty reasonable expectation from any orthopedic surgery, be it a rotator cuff repair, an ACL reconstruction, certainly a knee or a hip replacement, or a shoulder replacement. It is not uncommon to have some discomforts and stiffness and irritability up to a year, but after that, no, it should not happen. It should not be painful. So there is a very big difference between, “like I am still aware of it” versus “this thing I can not put weight through it. It hurts so much. I can not walk. I can not sleep. I can not ascend or descend stairs. I can not lift my leg to put it into a car.” These are things that I have seen in failed hips.

Clay: Yes.

Amy: Or even just give way where you weight bear on the leg, on that failed hip, and they will fall. That is a result of a failure.

Part 3 next week.

My friend Amy Dougherty is a physical therapist in North Carolina and operates Outer Banks Physical Therapy. She is a graduate of the University of North Carolina at Chapel Hill (where I also attended college and law school). She is an outstanding physical therapist and is beloved by her patients on the Outer Banks. Amy answers many of your questions about hip replacement surgery, metal-on-metal artificial hips, and the problems that have arisen from these hip products.

Clay: I want to focus on hip replacement surgery and I know you work with patients who are dealing with that kind of surgery every week. So let me start by asking what are a few reasons a person might need a hip replacement surgery?

Amy: You know, the most common reason is arthritic changes in the hip. So basically arthritis, that is the most common reason. Other reasons can include things like trauma. Some people have congenital mal-alignments where, it is basically called dysplasia where through the process of their development in utero and then following their bony surfaces of the femur, that is the long thigh bone and the acetabulum which is in the pelvis. They do not form correctly, so they might have ill-formed femoral heads. They might have ill-formed or ill-shaped acetabulum. So, the ball and the socket are not really designed well to weight bear. So, a lot of folks that, especially in a young population, that have early onset hip replacements. It is more likely the result of some type of congenital dysplasia. It could be a trauma. So, but arthritic changes is the number one reason and I have total hip replacement patients in my clinic every day. Very popular surgery, yes.

Clay: Very common especially once you get into the middle age and even older.

Amy: Absolutely. It is very common.

Clay: Well, how soon would physical therapy start after a total hip replacement?

Amy: Typically, the PT shows up within 24 hours of your surgery when you are in the hospital. So, what you can expect is basically after you come out of recovery, the physician or the nurse will come and talk with you and tell you when you will start your first PT. Sometimes, it is within 12 hours. It really is all dependent on the amount of time that is projected to be your discharge. Time or day, and that is something that actually frankly is changing dramatically over the course of the last 18 to 24 months. So total hip replacement surgeries are moving from being a two-day event in the hospital, which is what we used to see very commonly, to most likely being a predominantly outpatient surgery within the next five years.

Clay: Outpatient surgery–is that right?

Amy: That is right, and there is some pretty reasonable science to support why transitioning to outpatient is a great idea and is basically because of infection rates and things like that. And so, they are looking, I mean they being the world of orthopedic surgeons and the world of joint replacement specialist. They are looking to transitioning. It is already happening in some places, not on the Outer Banks, but it is happening in some larger cities where they are doing small groups of folks who are good candidates, so they are essentially very healthy people who frankly do not need to be hospitalized. They can go to an Ambulatory Care Center and safely receive a total hip replacement and go home that same day.

Clay: Could it also be maybe that recovering at home is a happier place for people?

Amy: No question. All of us would rather be home than at the hospital, and so the biggest issues that come into play are first and foremost safety, so you have to be safe to go home. Once you are in the recovery room you have to be medically stable. Pain needs to be adequately manage and that is something within the Joint Replacement Community, that is really becoming more and more well-researched and well-managed is how to keep people comfortable while they are recovering from this very big surgery. That is a big event, so managing the pain, making sure that they are safe to ambulate because you can walk on that new hip pretty much as soon as their block wears off as soon as anesthesia allows.

Clay: So whenever you come home, whether it is the same day or a couple days later and the patient is able to get to your office, how soon– so walk us through what PT might look like in the first visit to your office and then in the weeks that follow.

Amy: Typically, I will sometimes see people that are coming straight from the O.R. Basically, they may spend a day and a night in the hospital they come home and they are usually starting with me within a day or two of being home. So sometimes I will see them immediately post-op, some surgeons want those patients to be seen at home anywhere from two to four weeks. Generally based on surgeon preference. Sometimes it has to do with family logistics in that patient might live alone. They can not drive those first couple of weeks. So there are some issues that play into the decision making on whether they start outpatient, which is my clinic, or whether there is seen at home for home-based physical therapy. But if you come to my clinic the first thing that is going to happen is you are going to undergo an assessment, and that is basically where after doing a bunch of intake paperwork, where we make sure that you are actually medically stable, we start talking about your function. We start talking about “Hey, how are you doing?” What is your pain like?” We use pain scales and I expect because it has become such a big movement in orthopedics to better manage people’s pain so that they move.

Because we know that one of the things that is most helpful after joint replacement surgery, be at a hip or knee, is the ability to move. If you have got so much pain, you can not move all of a sudden, your risk factors go up substantially in regards to blood clot or onset of pneumonia. So, we know that moving is important. We will talk about your pain. Make sure that your pain is being adequately managed and then we will start looking at that lower extremity. I will have you walk for me. I will look at edema, will look at bruising, depending on whether your surgical dressings are off or not. I will look at the surgery site. Make sure it all looks good clean and dry, occlusive bandages or it should be in place at that point and then, just basically initiate the onset of PT which is assessing, and then addressing strength loss this most in deficits. We spend a lot of time talking about precautions, because there are some precautions after hip replacements depending on the approach that the surgeon has taken. So, there are some options available in regards to whether you have what is called an anterior approach or posterolateral approach. And so, there are some precautions and we make sure that the patient is well versed in that, and understands why the precautions are important. And then, we start to exercise, we start to move.

Clay: I know it is different for different patients based on how fit they might be, how young they might be. But how long does that therapy last working with you? And then when do you say “Okay, you are free to go but take these exercises home with you and make sure you do them”?

Amy: We start immediately. We start the first day they are there. Nobody leaves my clinic without having things to work on at home.

Clay: And so how long do those exercises last with you versus when you say “Okay you are released from me and you can do these at home without me”?

Amy: Frankly, it depends, and what I have come to realize through a lot of years of clinical practice is the fitness level that someone takes into the operating room. Absolutely dramatically affects how long they are with me. So, if you are pretty active, pretty strong, pretty fit, you just have a bad hip, and you can be all those things by the way, and still have a bad hip. So if you are pretty mobile and you have maintained pretty decent strength pre-op, you are not going to spend much time with me. A couple weeks, maybe. If you are really debilitated and we see this very commonly in people who have really put off having the joint replacement, maybe waited a lot longer than they should have.

Sometimes, there is a concomitant problems going on at the knee, at the foot and ankle, on the contralateral side, will see some problems that affect their ability to ambulate. And at the end of the day, with a hip replacement, our goal is generally normalize gait. I mean, that is what we are looking for and everything that normalized gait entails and so that strength, mobility, balance, neuromuscular control of the extremity. So at the end of the day, that is really what we are looking for is normal gait.

That is what frankly people that are having their hips replaced, they will tell you “I can not walk. I can not ascend or descend the stairs.” I live at the beach, you know people’s inability to get onto the beach is a huge issue. So because you take gait, and now you put it on an unstable surface like sand and the demands are exceptionally greater to be able to walk the beach than are to walk on the sand. So that is something in that first visit that we talk about “What are your goals?” I will specifically ask the patient when I am interviewing them, when I am evaluating them “What are your goals?” [and] “What is it that you have this hip replacement for a reason?” [and] “It is an optional surgery. Your life did not depend on you getting a hip replacement. So, what are your goals?”, “What did you decide, you have decided to make this commitment of time, money, risk, you have done those things to do something. Is it to be able to get through the night without pain?” For some people, that is their ultimate goal. Most people, it is mobility. I want to be able to get onto the beach, you know, some people I work in a beach community. I have patients that their goal is: I need to get back on my surfboard.

Clay: Right.

Amy: If it is somebody who basically just wants to be able to grocery shop and, be able to get their groceries in and out of their car independently and walk with a normal gait, unless they are profoundly weak when we start, it is not going to be too long. So, I know that is a ridiculously vague answer.

Clay: No, everybody’s different.

Amy: But fundamentally, everybody’s different with what they bring into the operating room and everybody’s different with their expectations following. So, the way I rehab a 35 year old, and the expectations and the demands that 35 year old is going to place on that new hip is going to be profoundly different than my 82 year old.

In Part 2, Amy and I discuss recovering from hip replacement surgery, returning to activity and even sports after hip surgery, and the importance of getting active and staying active.

COVID-19 has altered everyone’s schedule. Schools, colleges, and restaurants have closed. Even courts have shut down for non-urgent hearings and trials. In June, Judge Catherine Blake, overseeing the Smith & Nephew Birmingham hip litigation, issued an amended Case Management Order to extend discovery deadlines and bellwether trial dates for the multidistrict litigation.

Remember the Smith & Nephew Birmingham hip MDL is moving forward on two tracks: one set of cases involve the BHR components that were used in hip resurfacing procedures, and a second set of cases (“THA Track”) involve those individuals who received Birmingham hip components as part of a total hip arthroplasty (THA). Let’s breakdown the recent schedule changes for each track:

BHR (Resurfacing) Track:

Amended Case Management Order No. 16 has rescheduled the first BHR bellwether trial for May 25, 2021 and the second bellwether for July 26, 2021. This means the new CMO has pushed these trials out six months. It’s disappointing that we won’t get our first Smith & Nephew jury verdict by the end of this year, but totally understandable in these unprecedented times.

Discovery is the sharing of documents, materials, information, and evidence between the plaintiffs and the defendant prior to trial. The close of “general liability fact discovery” for BHR Track cases is now July 15, 2020, and case-specific fact discovery will be completed by October 20, 2020.

Expert discovery deadlines for both sides, which includes expert disclosures, expert reports, and depositions, now stretch from July 15, 2020 to October 30, 2020.

For the cases chosen to be considered for bellwether trials, case specific discovery will now run from November 30, 2020 through February 5, 2021.

Motions often follow discovery. These motions may involve one side’s challenge of the validity of expert testimony, or the admissibility of certain evidence, or the science behind certain claims. In the Smith & Nephew litigation, these motions will now be filed beginning November 30, 2020, and hearings on these motions will continue through June 4, 2021.

THA (Total Hip Arthroplasty) Track:

Discovery for the THA Track cases chosen as possible bellwether cases will end on December 1, 2020. From there, plaintiffs and defendant will select two cases to be considered for bellwether trials. Any additional discovery for these four cases will continue until March 12, 2021. Judge Blake has stated that she will issue a separate scheduling order for the THA Trial cases down the road.

Finally, the coronavirus is even changing the way the law is practiced. Many depositions are now being handled through secure video conferencing (remote depositions). While in-person depositions remain the gold standard, remote/video depositions are now being pressed into service to encourage social distancing. Judge Blake issued CMO No. 17 to set forth guidelines for handling remote depositions. These things can be a bit clunky, such as when you are handing over several exhibits for the deponent (the person being asked questions under oath). CMO No. 17 attempts to provide guidance on these issues for the Smith & Nephew Birmingham litigation, including authorizing the use of a deposition “concierge” to help with technical issues and even to hand over exhibits.

In general I think video depositions are great. Setting aside the health advantages in a pandemic, video depositions cut down on travel and litigation expense. I believe the legal profession should always do whatever it can to reduce the costs of litigation, as these costs inevitably reduce net awards for plaintiffs. So that’s a small bit of good news. I suspect when this pandemic is behind us, many of the changes created by the need for social distancing will remain because it simply works better.

The Takeaway:

Multidistrict litigation involves hundreds and often thousands of individual plaintiffs, from all across the country, who have been injured in similar ways by a defective product. Even without a pandemic it takes years to corral this information, to try bellwether cases and to negotiate fair settlements. The COVID-19 pandemic has caused delays in the Smith & Nephew Birmingham hip litigation and will likely cause further delays. You should always be patient when you have a case in any MDL; now you must be especially patient.

As always, you can call me to discuss your potential case: (919) 830-5602. Good luck!

Hip replacements often use a variety of exotic metal alloys or ceramics to recreate the ball-in-socket mechanism of the human hip. A total hip replacement will typically consist of four parts:

• The socket (or acetabular component).
• The ball (or femoral head) that goes into the socket.
• A liner for the socket that is in direct contact with the ball.
• A stem for the ball (also known as a femoral stem) that connects the ball to the thigh bone (femur).

The liner is placed into the socket and the socket is placed into the pelvis. The ball attaches to the stem and the stem attaches to the femur. The result is a total artificial ball-in-socket hip replacement.

Sometimes, these hip replacements don’t work as expected. One such example comes from Zimmer US, Inc. and related companies (which we’ll collectively refer to as “Zimmer”). Many patients have reported problems with a particular set of Zimmer femoral head and stems.

What’s Wrong with Zimmer’s Artificial Hips?

At issue are two femoral stems: the M/L Taper Hip Prosthesis and the M/L Taper Hip Prosthesis with Kinectiv Technology. When either of these components is paired with the Zimmer VerSys Hip System Femoral Head, many artificial hip recipients have reported a variety of problems, such as:

• Metallosis (elevated metal levels in the body)
• Osteolysis (destruction of bone tissue)
• Pseudotumor formation

Often, any of these problems require revision surgery, which is surgery to replace the failed implant. It’s believed that many of these hips are failing due to corrosion, trunnionosis and the release of tiny bits of metal at the point where the femoral head connects with the femoral stem.

Have Patients with Failed Zimmer M/L Hip Replacements Taken Legal Action?

Yes. There have been hundreds of plaintiffs who have filed suit against Zimmer alleging defectively designed and manufactured hip components, Zimmer’s failure to warn patients and doctors about the risks of using the hip replacement and that Zimmer did not properly test the artificial hip components.

With so many lawsuits consisting of similar injuries and allegations, along with a single (or small number) of defendants, our court system has a special system in place to consolidate the cases for pre-trial matters. This consolidation is called multi-district litigation, or MDL.

The purpose of MDL is to handle much of the pre-trial matters, such as discovery, in a single court with a single judge. With a single judge handling these pre-trial matters, the cases can be processed more efficiently, as the judge’s decisions will apply to all cases at the same time.

The ultimate goal is to reach a comprehensive settlement that resolves all of the cases fairly. One way to do with is by having several bellwether trials. These sample cases are supposed to be representative of most of the cases in the MDL. Therefore, how they turn out can serve as a signal of what the plaintiffs and defendants can expect if their respective cases go to trial.

How these bellwether cases turn out will shape how settlement negotiations will go. As you can imagine, the better they go for the plaintiffs, the more negotiating leverage plaintiffs will have during settlement talks.

Right now, the Zimmer lawsuits involving the M/L Taper Hip Prosthesis, the M/L Taper Hip Prosthesis with Kinectiv Technology and the VerSys Hip System Femoral Head are in MDL in the US District Court for the Southern District of New York before Judge Paul A. Crotty.

Zimmer MDL’s Current Status

The Zimmer MDL is in the discovery phase, with the first bellwether trial scheduled for January 25, 2021. But if this date is pushed back, don’t be surprised. It was originally scheduled for September 14, 2020, then pushed back to October 19, 2020 and now has this date in early 2021.

All of this to say, there’s a lot of discovery and pre-trial motions to complete before a single trial takes place. As new developments arise in this case, I’ll post an update in this blog. Until then, there’s a long grind of pre-trial matters to get through.

Call me to discuss further: (919) 830-5602.

It Works This Way:

Let’s say your job is intense and over the years you begin to neglect your physical fitness. As you get a little older, in this sedentary state, you begin to gain weight. Gaining weight makes you less willing or able to exercise and you gain even more weight. Soon you start to feel aches in your hip or maybe your knees. This pain, over time, gets worse. Finally you consult an orthopedic surgeon, who recommends a total hip or knee replacement. Because you are a trusting soul, and because the hip pain is getting worse, you schedule hip replacement surgery. At this surgery your doctor implants the latest metal-on-metal (MoM) artificial hip components. A year or two later a new kind of hip pain develops, and this hip pain gets severe quickly. Your surgeon does blood work and tells you that your metal levels have spiked in your body and–of yeah, one other thing–you also have a “recalled” artificial hip implanted and that it needs to come out. So you are now forced to undergo revision surgery, and you eventually find your way to me to file a lawsuit over the injuries you sustained from this defective medical device.

Weight Gain and Obesity Cause Health Problems

It’s no secret that weight gain causes all kinds of health problems. Doctors will tell you that substantial weight gain and obesity causes heart disease, high blood pressure, diabetes, gout, even sleep problems. Obesity is also the most common cause of joint discomfort. Obesity can lead to osteoarthritis and can pressure otherwise healthy joints; over time this added wear and tear can cause a person’s joint to breakdown, requiring hip replacement surgery, a surgery that may have been unnecessary if the person could have maintained a healthy weight. And that’s my point: if we can keep our weight at healthy levels, we can possibly avoid the unintended consequence of having a defective medical device implanted in our bodies.

No Shame or Blame

We are all vulnerable to weight gain. Years ago I was working too much, stopped exercising, and gained quite a bit of weight without even realizing what was happening. When I returned to exercise I was only able to walk on a treadmill for fifteen minutes. But soon I was running, lost twenty pounds in ninety days, and I have been able to keep the weight off ever since. So I get it: weight gain is one of the more insidious conditions of aging. It’s not easy to keep extra weight off, especially as we age and our metabolisms slow. But I would like to know how many defective product lawsuits would have been avoided if all those joint replacement surgeries made necessary by substantial weight gain could have been avoided.

The Takeaway?

If possible, keep exercising and keep your weight down. It could save you from all kinds of health problems and even from becoming a victim to a negligent company selling defective medical devices. In this age when device manufacturers are being more aggressive in rushing products to market, one sad result is that thousands and thousands of innocent people have been hurt by defective artificial hips, knees, and other medical devices. Don’t give these companies an opening to make you the next victim.

I get this question fairly often, and it’s a good one. It usually goes something like this: a person had a total hip replacement several years ago. A few years pass. Then out of the blue the individual receives a letter from the artificial hip manufacturer or from the implanting surgeon explaining that a recall has been issued for the artificial hip components implanted. (And these are the lucky patients; many people who receive an artificial hip that was later recalled never get notification from their doctor, the manufacturer, or anyone. They don’t discover they have a defective artificial hip until the pain, metallosis, or other injury develops.) If I were in this position, and I received a recalled artificial hip, I would want to know: Should I have the recalled hip removed? And should I have the hip removed immediately?

As with most things in life, the answer is not simple.

I have been a product liability lawyer for many years now, and in that time I have spoken with hundreds of people suffering from defective products. I have heard dozens of variations on a similar narrative. While this is neither medical nor legal advice, here are my suggestions:

Don’t panic. Panic never helps, whether you are confronting a decision on revision hip surgery or trying to escape from a bear. (I know, this is easy for me to say.) You do not need to rush out and schedule emergency surgery as soon as get the recall letter. But you should start taking deliberate steps to find answers to your questions and to protect your health, which means first:

Take stock of your physical condition. How do you feel? How does the hip function? Do you feel any pain? Any other symptoms? Can you still exercise, or have you slowly given up many of the physical activities you used to enjoy? What has your doctor said to you in your recent office visits related to the condition of the hip replacement?

Schedule an appointment with your orthopedic surgeon. You need to meet with your orthopedic surgeon and ask him all the questions you have about the recall and the implanted artificial hip: why was it recalled? what is the defect? how has the defect harmed people? what symptoms can the defect cause? And of course: should I get the revision surgery?

Get metals levels checked. As part of this visit with your surgeon, you will want to have him or her order lab work to check your cobalt and chromium levels. Even artificial hips that are not metal-on-metal (MoM) can leach metals into the blood and tissue. It is important to get blood work done to see if you have elevated metal levels.

Do your research. Read as much as you can about the recalled artificial hip, starting with the FDA website but also working your way to reputable news sources. Find out what is defective about the artificial hip and what problems it is causing when the hip fails.

Self-assess. What is your level of anxiety? Are you the kind of person who will suffer with the idea of a recalled product in your body, even in the absence of serious symptoms? Or do you trust your surgeon to give you good advice on revision surgery? If your hip feels good and you have no anxiety, you may be able to hold off on revision surgery. As part of this step, it would also be helpful to discuss revision surgery with your spouse, your family, and even with trusted friends.

Get revision surgery if you need revision surgery. Once you go through the steps above, you and your surgeon should have a long discussion about the pros and cons of revision surgery. No surgery is low-risk, so you need to make this decision deliberately and carefully. If you have pain, and if you have elevated metal levels, your surgeon will most likely advise revision surgery. On the other hand, if your hip is functioning well, and you have no discernible metal levels, and you otherwise feel fine, you and your surgeon may decide to take a wait-and-see approach. In this case, however, you need to maintain vigilance: schedule periodic metal blood tests, arrange frequent follow-ups with your surgeon, and keep a symptoms journal if they arise.

If necessary, seek out a second opinion. It is vital that you trust your surgeon. If you feel you are not getting your surgeon’s full attention or consideration, find another orthopedic surgeon. Ask around for trusted surgeons in your area. Go through the process with the new surgeon. Occasionally some surgeons have reasons for dismissing the importance of recalled medical devices like artificial hips, so they may downplay the importance of removing the recalled artificial hip. (I’ve known at least one surgeon who said high metal levels were not a health risk.) Above all, you should always rely on doctors you trust to make decisions on surgery.

This is not legal or medical advice.