Our Attorneys Explain the Exactech Knee Polyethylene Insert Recall

In February 2022, Exactech recalled hundreds of thousands of knee and ankle replacement devices that were implanted into patients between 2004 and 2022. The knee and ankle inserts had inadequate packaging that failed to protect the parts from exposure to oxygen before being implanted into the body. Oxidation can cause the inserts to significantly degrade over time, leaving many patients in pain and facing the possibility of revision surgery.

At Searcy Denney we have decades of experience representing hip and knee implant failure clients. We are here to answer all of your questions. If you, a loved one or friend received an Exactech knee replacement between the years of 2014 and 2022 Contact an Exactech knee replacement attorney at our firm to learn about your legal options.

Why was the Exactech Knee Implant Recalled?

The recall for knee and ankle replacements is due to a packaging defect. It is important for the inserts to not come in contact with oxygen before being implanted into the body (for example, while being shipped and stored prior to your knee surgery). The packaging layers for the plastic inserts in this recall were found to have allowed airflow prior to insertion, which causes oxidation and premature wear. The components and inserts manufactured over the last 8 years were packaged in oxygen resistant vacuum bags but were missing a barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance. 

Many Exactech patients have received a very concerning letter from their surgeon and have a lot of questions. A device recall leaves patients questioning whether they have an Exactech joint replacement and, if they do, what actions they need to take to determine if the recall impacts them personally. At Searcy Denney, our experienced defective medical device attorneys can help find these answers for you and determine if financial compensation may be available for you and your family as a result of an Exactech knee replacement lawsuit.

What Are the Complications Linked to the Exactech Knee Replacement Recall?

Exposure of the knee replacement device to oxygen prior to being implanted in the body can cause oxidation, which means the plastic can wear out earlier than expected and potentially lead to bone loss. It can become damaged in the patient’s body — essentially causing knee implant failure. Symptoms patients may experience include:

• Knee swelling
• Pain while walking
• Inability to bear weight on your implant
• Grinding or clicking
• Overall instability

Unfortunately, premature wearing of the plastic component can lead to the need for knee revision surgery. If you or a loved one had knee surgery with a defective insert, you have legal options, and an attorney at Searcy Denney can help determine if you qualify for compensation. 

5 Important Facts for Patients Who Have Exactech Knee Replacement Devices

Here are five more important facts for patients who may be suffering from an Exachtech knee implant injury. 

1. Exactech Has Recalled All Optetrak, Optetrak Logic and Truliant Knee Implant Devices Sold Since 2004

Exactech’s knee replacement device recall covers all Optetrak, Optetrak Logic and Truliant devices sold between 2004 and 2022. This means that nearly 150,000 defective knee replacement devices have been recalled. If you have received an Exactech knee replacement device in the past 18 years, you should consult with your doctor to find out if you may need corrective revision surgery.

2. Exactech Began Recalling Its Knee Replacement Devices in 2021

While Exactech recalled all of its Optetrak, Optetrak Logic and Truliant knee replacement devices in 2022, the company began with a smaller recall in 2021. This original recall applied only to devices with a remaining shelf life of five years or greater. However, the company’s expanded recall now covers all devices—including those implanted in patients as well as those remaining on hospitals’ shelves.

3. It Appears Exactech Knew About Concerns Related to Its Knee Replacement Devices At Least As Early As 2017

The U.S. Food and Drug Administration (FDA) began receiving adverse event reports related to Exactech’s knee replacement devices at least as early as 2017. Thus, the company should have been aware of potential safety concerns related to its knee replacement devices at this time as well.

4. Exactech Obtained Approval for Its Knee Replacement Devices Using the FDA’s 501(k) Fast-Track Approval Process

While most medical devices go through a rigorous FDA approval process, Exactech’s knee replacement devices did not. Instead, Exactech used the FDA’s controversial 510(k) fast-track approval process. This process allows companies to obtain approval without extensive safety testing by claiming that their new products are “substantially equivalent” to products the FDA has already approved.

5. Patients Who Received Defective Exactech Knee Replacement Devices Can File Claims for Financial Compensation

If you received an Optetrak, Optetrak Logic or Truliant knee replacement device between 2004 and 2022, you may be entitled to financial compensation. When companies like Exactech sell defective medical devices, they can – and should – be held accountable. Our law firm has significant experience handling medical device cases, including cases involving defective joint replacement devices, and we can help you assert your legal rights.

Exactech’s Knee Replacement Devices Aren’t the Only Ones Leading to Lawsuits

As additional evidence of the problems with Exactech’s knee replacement devices, these are not the company’s only devices that are leading to lawsuits. The company is facing litigation related to its hip and ankle replacement devices as well. Unfortunately, it appears that Exactech sold multiple types of defective medical devices to health care providers and patients all over the country—and now patients must take legal action via an Exachtech knee implant lawsuit to protect their health and avoid bearing the costs of the company’s mistakes.

If you have experienced severe pain or other complications as the result of receiving a defective Exactech knee replacement device, you should:

• Collect Your Records – Collect any and all records you have related to your knee replacement. This includes records from your knee replacement surgery, records from your revision surgery (if applicable), employment records if you have missed time from work, and any other relevant documentation you may have.
• Continue to Follow Your Doctor’s Advice – At present, it does not appear that doctors had reason to be concerned about Exactech’s knee replacement devices until the company sent its letter. With this in mind, you should continue to follow your doctor’s advice—including your doctor’s advice regarding whether to undergo revision surgery.  
• Schedule a Free Consultation – To find out if you have a claim against Exactech, you should schedule a free consultation with a lawyer. At Searcy Denney, we have a team of lawyers who handle defective medical device claims, and we have recovered billions of dollars in compensation on behalf of our clients.

3 Important Facts about Exactech Knee Replacement Lawsuits

In addition to learning about the history of Exactech’s defective devices, patients who have received these devices should also take the time to learn about their legal rights. Here are five important facts about filing an Exactech knee replacement lawsuit:

1. You May Have Grounds to File a Lawsuit if You’ve Suffered from a Exactech Knee Implant Failure

Several Exactech knee replacement recipients have already filed defective product lawsuits against the company. If you received an Exactech knee replacement device and your device failed, you may have grounds to file a lawsuit as well.

2. By Filing a Lawsuit, You Can Recover Compensation for Your Pain and Suffering, Medical Expenses, and Other Losses

If you have grounds to file a lawsuit against Exactech, you can seek to recover all of the losses you have suffered (and will suffer) as a result of receiving the defective device implant. This includes your current and future pain and suffering, medical bills, lost income, and other financial and non-financial losses.

3. Exactech’s Letter to Patients and Doctors is Strong Evidence of Liability

The letter that Exactech sent to patients and doctors warning of the risks associated with its knee replacement devices is strong evidence of liability. Even if you did not receive this letter personally, our lawyers can use this letter in support of your claim for financial compensation.

FAQs: Filing an Exactech Ankle Replacement or Knee Replacement Lawsuit

If I Have an Exactech Knee Implant or Ankle Implant, Do I Need to Get it Replaced?

If you have an Exactech Optetrak, Optetrak Logic or Truliant  knee replacement device, you should consult with your doctor to determine whether you should get it replaced. It is possible that you may need revision surgery now, or your doctor may recommend waiting before making any decisions. Ultimately, since the oxidation that triggered Exactech’s recall leads to degradation over time, it is likely that the vast majority of implant recipients will need replacement surgery.

Should My Doctor Have Known about the Issues with Exactech’s Knee Replacement Devices?

Exactech sent its recall letter to doctors in February 2022 and immediately warned against use of the company’s Optetrak, Optetrak Logic and Truliant knee replacement devices. Currently, there is no suggestion that doctors should have been aware of issues with Exactech’s devices before this time.

How Long Do I Have to Sue Exactech for My Defective Ankle or Knee Implant?

Generally speaking, patients who received defective Exactech knee replacement devices have four years to file a lawsuit against the company. This limitations period runs from the date that patients learned, or reasonably should have learned, that they had a claim against the company for a defective medical device.

How Much Can I Recover from Exactech for My Defective Knee Replacement Device?

The amount you can recover from Exactech for your defective knee replacement device depends on your individual circumstances. While you may see average settlement figures in the range of $100,000 to $200,000, your claim could be worth more or less depending on the financial and non-financial costs you incur. Don’t forget, patients who received defective medical implants can sue to recover their current and future losses—and your future losses could far exceed the costs you have incurred to date.

What If I Have a Claim Related to an Exactech Hip or Ankle Replacement Device Instead of a Knee Implant?

In addition to handling lawsuits against Exactech related to the company’s Optetrak, Optetrak Logic and Truliant knee replacement devices, we are also handling claims related to the company’s defective hip and ankle implants. If you have received any type of Exactech medical implant, we encourage you to contact us for a free, no-obligation consultation. 

What is My Out-of-Pocket Expense to File an Exactech Knee Replacement Lawsuit?

If you have a lawsuit against Exactech, you can hire a team of experienced lawyers to represent you at no out-of-pocket costs. Our firm covers the costs of pursuing our clients’ lawsuits while they are pending, and we do not recoup our costs or collect any fees unless we help our clients win.

What Should I Do If I Had an Exactech Knee Replacement or Ankle Replacement Surgery?

Patients who believe they may be impacted by this recall, and who are experiencing pain, are recommended to reach out to your surgeon for a check up and further evaluation. Exactech will contact patients to ensure everyone is informed of the recall. As a consumer, and victim of a defective medical device, you have the right to consult with an attorney to learn your compensation options. 

Talk to an Exactech Knee Replacement Recall Attorney For Free Today

At Searcy Denney we fight for patients who are experiencing pain as a result of defective medical devices, including other Exactech implants, like the recalled Exactech Connexion GXL liners used in hip surgery. Because of our experience, we have answers to your most important questions. The Exactech knee recall means people are suffering from lingering pain after a knee replacement surgery that was supposed to enhance their life. 

We have experience with these types of defective medical device claims and understand how to recover the financial compensation you’re entitled to receive. Contact us to schedule your free consultation. We work on a contingency fee basis, with no risk to you.