Exactech Inc. (Exactech) has been having some legal troubles lately involving its hip, knee, and ankle implants. Some patients receiving these implants have suffered complications from the implant they allege are the fault of Exactech. There have been recalls for the affected products, but this hasn’t been enough to fully compensate the affected patients.

As you might expect, many of these patients have sued Exactech. Because there are a lot of cases with similar facts and issues (and they are also in the early stages of litigation), many of these cases have been consolidated into a multi-district litigation, or MDL.

One of the more recent updates in this litigation involves transferring many cases to a single federal district to centralize the legal proceedings. To better explain what this means, let’s first review what an MDL is.

An Overview of Multi-District Litigation

MDLs are a way federal courts try to streamline the legal process when there are many similar lawsuits filed all over the country. For example, a defendant company might have thousands of products that have affected thousands of customers. These customers are located all over the country and file suit in federal courts that are also located all over the country.

Because of the similarities between the cases, it’s possible to consolidate part of the litigation process (such as discovery) into a single federal court. This can improve the efficiency of the litigation, reduce conflicting court decisions dealing with the same issues and make it easier for the cases to settle

The Exactech MDL Transfer Order

Issued by the Judicial Panel on Multidistrict Litigation (JPML), the transfer order centralizes the Exactech MDL cases to one federal district court. Specifically, the cases will be sent to the Eastern District of New York (EDNY) and assigned to Judge Nicholas G. Garaufis. Many of the plaintiffs supported transferring the MDL cases to the EDNY. However, some also suggested the Eastern District of Pennsylvania and the Southern District of New York.

Exactech expressed a preference for transferring the cases to the Northern District of Florida, the District of South Carolina and the Eastern District of Louisiana. There are several potential explanations as to these preferences, but one commonality among most of them is that the plaintiffs’ choices tend to have juries and judges that are more likely to be plaintiff-friendly while Exactech’s preferences are more likely to be defendant-friendly.

Why Did the JPML Choose the Eastern District of New York?

In explaining its decision in the transfer order, the JPML choose the EDNY because:

• Many MDL cases were already located there.
• The EDNY isn’t as busy as many other federal district courts.
• Several important witnesses are located in or around the EDNY.
• Judge Garaufis has plenty of experience handling MDL cases.

Why Do Litigants and Defendants Have Preferences for Courts that Handle MDL Cases?

In addition to choosing a district that’s more likely to have a judge or jury panel that’s sympathetic to a particular side, other reasons to select one federal district over another include:

• More plaintiffs and/or key witnesses are located in the district, so there’s less of a travel burden placed on them.
• Important evidence is located in that district.
• How busy the district is and how quickly either side wants to get through the litigation.
• Prior legal decisions from the district favoring one side over the other.

Do You Have Additional Questions Concerning the Exactech MDL Transfer Order?

If you’ve decided to sue Exactech and this transfer order affects your case, you pretty much have no choice but to go along with it. If you’re thinking about suing Exactech for an allegedly defective implant, there’s a reasonable chance this transfer order could affect you.

To learn more about what’s going on, you should get a consultation with a product liability lawyer. If you have one in mind, give them a call. If you’re not sure whom to contact, don’t hesitate to call me at (919) 830-5602 and I’ll see how I can help. Good luck.

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.

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.