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.

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.

The Attune Artificial Knee

The DePuy Synthes Attune artificial knee is marketed as an “innovative, comprehensive, integrated knee system” that provides stability, strength, and a greater range of motion post-surgery. This novel design was created to be a better approach to traditional knee replacements. But many people have experienced complete failure of their Attune knees shockingly soon after surgery.

To understand what goes wrong, let’s first consider how an artificial knee is supposed to work. The replacement joint has to sit right where the knee originally was, connecting the femur, or thigh bone, with the tibia, or shin bone. The new knee must be firmly attached to both bones or it won’t work. Imagine a single hinge holding a door onto a wall and allowing it to swing. If the hinge comes detached from either the wall or the door, the door will pull away from the wall and fall down as it swings.

Last year, a group of orthopedic surgeons reported in The Journal of Knee Surgery that this is exactly what happens with a disconcertingly large proportion of Attune artificial knees. While the replacement joint remains solidly cemented to the femur, the lower bond to the shin has a tendency to fail. The cement that should hold the knee to the tibia binds to the bone but not to the Attune device itself. Therefore, the detached joint floats, and just like the failed hinge that allows the door to fall, the replacement knee can’t hold any weight.

People with defective Attune knees experience significant knee pain, especially when they try to bear weight on the knee when standing or walking, as well as a restricted range of motion. The study revealed that these problems sometimes occurred within just a few months of the original knee replacement.

The only way to correct a failed Attune knee is to undergo a second or “revision” surgery. That second surgery—where the useless cement must be removed from the tibia and the solid femur connection must be broken—is more involved and more painful than the initial knee replacement procedure. To make matters worse, the surgeons’ report indicated that the separated knee generally doesn’t show up on X-rays; it can only be detected during the revision surgery. In other words, a doctor may not realize that the replaced knee has failed.

The Attune knee’s defects are further evident in the U.S. Food and Drug Administration’s Medical Device Adverse Events (MAUDE) database. Even though MAUDE is a self-reporting system, such that only the manufacturer, DePuy Synthes, can report its knees’ failures, there are dozens of recent reports. The Attune knee has been redesigned and may now be less prone to separation from the shin bone, but the original design has not been recalled, and the recipients of that faulty device have been left to fend for themselves.

Fortunately, DePuy Synthes is now being forced to answer for these defects in court.

The Attune Lawsuit(s)

Last September, a law firm filed the first lawsuit involving a defective Attune knee in Tuscaloosa County, Alabama. The case alleges that its client’s artificial knee failed prematurely, resulting in substantial pain, delayed recovery, and significant medical expenses. Expect to see more lawsuits in the future involving Attune knees. These cases are likely to involve not only damages for pain and suffering but also for the costs of the second replacement knee surgery and the accompanying physical therapy.

Have you had a knee replacement that ultimately failed or that caused more problems than it solved? We can advise you whether you may have a case against the manufacturer or another involved party. Please contact us to talk with a lawyer about your situation.

The Zimmer NexGen artificial knee has been causing patients much pain and suffering over the past decade. Zimmer first instituted a recall of one group of NexGen components in 2010, and there have been other recalls in the years following. Many patients with the NexGen knees have suffered pain and an inability to maintain normal physical activity. The lawsuits of course followed.

In August 2011, to handle the growing number of lawsuits over the NexGen knee, a multidistrict litigation (MDL) site was formed in Chicago, Illinois and assigned to federal district court judge Rebecca Pallmeyer. The MDL is titled: In Re: Zimmer NexGen Knee Implant Products Liability Litigation, No. 2272 (1:11-cv-5468).

Do You Qualify for the Zimmer NexGen MDL?

The overarching requirement to participate in the MDL is (1) to prove implantation of the Zimmer NexGen knee components (with product stickers from the original surgery), and (2) to show through the medical records clear evidence of loosening. Loosening is when the artificial knee components begin to move in the patient’s leg and separate from the bone. This is not good. Loosening can be very painful. A loose artificial knee will cause major complications and eventually require replacement and revision surgery. When a patient complains to an orthopedic surgeon about knee pain after a total knee arthroplasty, the doctor will order an X-ray. The doctor will look for radiolucent lines, which are spaces between the artificial knee component and the patient’s bone. Essentially, small gaps occur because the medical device is not implanted tightly or securely to the bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure. The spaces often fill with fluid or tissue which can cause additional loosening of the medical device.

more Zimmer NexGen Knee Was Approved Through the 510(K) Process

The Zimmer NexGen artificial knee bypassed the normal premarket testing for new medical products through a process known as “510(k).” I have written about this “rush to market” procedure on this site. The 510(k) process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 (MDA) of its intent to market a device (like the NexGen knee); the manufacturer must describe the new device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States without rigorous testing as with new medical devices. This is how the Zimmer NexGen Knee reached the market.

Large numbers of people have suffered from pain and required revision surgery to replace the Zimmer NexGen artificial knees. Despite all this suffering, the MDL has moved very slowly. Bellwether cases have been selected, and trial dates assigned, only to be continued or otherwise postponed. For individuals who filed suit against Zimmer years ago (including some of my clients), it has been a frustrating exercise. Over the years, the qualifications in the MDL have narrowed, and the requirements to qualify for potential compensation have gotten more difficult. As a result, many lawsuits have been dismissed from the litigation as not qualifying under the latest criteria.

Case Management Order No. 11 (The “Lone Pine” Order)

On June 24, 2016, MDL Judge Rebecca Pallmeyer issued the latest case management order (CMO) which set out the latest requirements to determine if a case has “sufficient merit to proceed to trial.” The new order, which is referred to as a Lone Pine Order, requires each plaintiff to file an Expert Declarations form establishing that the case meets all the latest requirements to warrant its day in court (that is, a trial by jury). These requirements are complex and come from different court orders over several years, but I will try to set them out (in simplified form) here. The plaintiff must:

• File a Plaintiff Fact Sheet (which details the key facts of the case);
• Show Evidence of Loosening of the Zimmer NexGen knee;
• Submit Evidence of Knee Flexion of 120 Degrees or Greater;
• Identify the Case as Track One or Track Two (Track Two is essentially a case where the requirements of Track One have not been met);
• Designate Whether the Plaintiff Intends to Pursue Certain Specific Claims, Such as:
  • Femoral loosening resulting from high flexion activities;
  • Loosening of tibial component;
  • Tibial loosening of MIS tibial component with a drop down stem.

I know, I know, what the heck does all this mean? It is highly technical, and an orthopedic surgeon or a competent medical device attorney is often necessary to make sense of these directives. For now, let me say that this case management order presents a new challenge for the plaintiffs involved in the litigation. These requirements are precise and rigorous and designed to weed out cases which do not have medical records clearly showing evidence of artificial knee loosening, along with injury and pain for the patient. Undoubtedly, this Lone Pine Order will cause some of the cases to be abandoned. But if you have a Zimmer NexGen knee implanted, and it failed, and the failure led to revision surgery, you should find a good product liability attorney to review your case thoroughly and see if it qualifies under the latest guidelines. But do not delay.

The first bellwether trial in the Zimmer NexGen MDL is scheduled for October 2016. Let’s hope it does not get postponed (again).

“The Most Anatomically Accurate Knee Implant”

In 2012, medical device manufacturer Zimmer, Inc. introduced the Persona artificial knee to the public with lofty language. Zimmer announced that the company was “redefining knee arthroplasty and ushering in a new era of personalization with the introduction of the Persona Knee.” Zimmer stated on its website that by “working with more than 50 of the world’s most respected orthopaedic surgeons, and utilizing analytics from both genders and 1,500 different bone types from 26 different ethnicities, Zimmer was able to create the most anatomically accurate knee implant.”

The reported advantage of the Persona knee system, according to Zimmer, was that it would give surgeons several component options for each patient and each surgery, thus assuring a tailored fit for the patient. Again, from Zimmer: “the result is an implant system that addresses the unique needs of the patient and accommodates surgeon-specific preferences — all while empowering surgeons to minimize “trade-offs” and better optimize results.” Sounds great, doesn’t it?

Zimmer sold the Persona knee from November 2012 through March 2015. A lot of them. But bad things began to happen. People began reporting pain and other symptoms, including loosening of the knee components inside the leg.

more The Zimmer Persona Knee Recall

In March 2015, Zimmer, Inc. issued a voluntary recall of the Persona Knee. The actual recalled component was the Persona Trabecular Metal Tibial Plate. Zimmer sent an “Urgent Medical Device Recall” letter to surgeons and risk managers, and then notified the Food and Drug Administration. The FDA announced the recall on its website:

“Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately. The Inventory Return Certification Form should be completed and returned along with the recalled product. Customers may contact the following with any questions: 1-877-946-2761 between 8:00 am and 5:00pm EST.”

Note: For readers in the Carolinas, the recall impacts North Carolina but not South Carolina. Plainly, the Zimmer Persona knee was marketed, sold, and implanted in North Carolina (and many other states).

What Are Radiolucent Lines?

Radiolucent lines are spaces between the artificial knee component and the bone. Essentially, small gaps occur because the medical device is not implanted tightly or securely to the bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure. The lines or spaces can fill with fluid or tissue and can cause additional loosening of the medical device.

The actual definition of “radiolucent” is that open space which is visible on an X-ray, one which shows an opening or gap where an opening or gap should not be visible.

What is Loosening?

Loosening is when the artificial knee begins to move in the patient’s leg and separate from the bone. This is a bad thing. Loosening can be very painful. A loose artificial knee will cause major complications and eventually the need for replacement and revision surgery.

Some of the physical symptoms of a failure of an artificial knee include pain, stiffness, swelling, and instability in the leg or around the knee.

Persona Knee Was Approved Through the Dreaded 510(K) Process

Like many of the metal-on-metal artificial hips entering the market in the last ten to fifteen years, the Zimmer Persona artificial knee bypassed the normal and vital pre-market testing for new medical products through a process known as “510(k).” I have written about this problematic loophole often on this site. The 510(k) process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 (MDA) of its intent to market a device (like the Persona knee) and to describe the new device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States without rigorous testing as is required for new medical devices. This is how the Persona Knee reached the market.

The recall of the Zimmer Persona Knee currently impacts as many as 11,658 patients (this is the “quantity in commerce” as of March 2015). This latest potential mass failure of a medical device is a very recent development, and no multidistrict litigation (MDL) court has been chosen. But it will, and likely soon. For more information on MDLs, check out my article:

https://www.northcarolinaproductliabilitylawyer.com/multidistrict-litigation-work/

If you received an artificial knee on or after November 2012 and have developed pain or other symptoms in the knee or leg, you should have received a recall letter directly from Zimmer, Inc. But even if you did not receive this letter, you should confirm with your surgeon whether the Zimmer Persona Knee was implanted. And keep a close watch on your artificial knee.