If you had ankle or knee replacement surgery between 2004 and 2022, pay attention. Many medical device manufacturers have recalled their knee replacement implants over the past decade. The most recent recall comes from Exactech. In fact, the Food and Drug Administration has issued a recall of the Exactech Class II knee.

Faulty knee replacements can cause significant physical and financial consequences. You could endure months or years of pain before you finally have the money to undergo another knee surgery. In some cases, defective medical devices force people to spend decades paying off medical debt. 

No one deserves this type of physical and financial struggle. That is why you need an experienced knee replacement attorney from People For Law on your side. We will protect your rights as we fight for maximum compensation.

Exactech Withdrawal Lawsuit Overview

On February 11, 2022, a lawsuit was filed in federal court against Exactech, Inc., an orthotic device manufacturer.

The Exactech recall lawsuit alleges that hip implants used in total arthroplasty are defective due to a faulty polyethylene coating. This coating, plaintiffs claim, causes rapid wear, leading to bone loss (osteolysis) and the need for further surgery. A hip liner is a component inserted into the artificial hip socket that interacts with the femoral head or ball.

Recall Issued for Exactech Connexion GXL Hip Liner

The Exactech hip liner in question is the Connexion GXL Liner, which is made from irradiated ultra-high molecular weight polyethylene. In marketing its Connexion GXL liners, Exactech says that the liners had less wear and would last longer than their competitors.

However, in July 2021, Exactech recalled its Connexion GXL acetabular liner following medical concerns. The polyethylene liner was prone to a high rate of early wear failure and severe secondary osteolysis.

Exactech Recalls Knee and Ankle Implant Devices

In addition to the hip recall, on February 7, 2022, Exactech recalled some of its knee and ankle devices. They also have polyethylene liners that lead to accelerated excessive wear, bone loss, and failure that require corrective surgery.

Exactech Withdrawal Lawsuit in Federal Court

The case was filed in the United States District Court for the Eastern District of Arkansas, Wilson et al. v. Exactech, Inc., Case No. 4: 22-CV-136-BRW.

In September 2013, the patient in the lawsuit underwent total hip replacement surgery and received several artificial components from Exactech, including the Novation Crown Cup Connexion GXL line. Less than eight years after the Exactech product was implanted, the plaintiff suffered severe pain and osteolysis. The plaintiff required revision surgery after that.

The victim of the Exactech recall class action lawsuit alleges that Exactech acted negligently. It failed to warn doctors and consumers about the unreasonable risk of harm from the device. Additionally, the plaintiff alleges that Exactech negligently made false statements about the 59% reduced wear rate for Connexion GXL polyethylene liner and that it had “improved polyethylene” with a lower wear rate.

Exactech’s History with the FDA

According to the Food and Drug Administration (FDA), the Exactech recall is classified as a Class II recall. The definition of a Class II recall by the FDA is:

“A situation in which use of, or exposure to, an infringing product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

In other words, device failure is certainly possible but unlikely to cause serious complications.

Has Exactech Obtained 501k Clearance from the FDA?

Yes, and this may be a partial explanation for why so many Exactech devices have failed. 501k clearance basically shortens the FDA approval process. Companies that register their products for 501k clearance do so because they believe their products are safe and effective. Therefore, companies believe that their products do not need to go through the entire FDA approval process to determine safety and effectiveness. 

If Exactech’s medical devices had gone through the entire FDA approval process, perhaps they would have discovered the packaging flaws. This is the main argument given by the mass tort attorneys.

Did Exactech Know About its Defective Implants?

The FDA began receiving reports of defective knee implants associated with Exactech in 2017. This means that the company should have been aware of the potential health dangers caused by its knee replacement systems.

According to an urgent medical device fix released in February 2022, the Exactech company recalled several ankle and knee replacement systems sold between 2004 and 2022.

Exactech Knee Recall Lawsuits

Have you had a knee replacement surgery and received an Extractech knee system between 2004 and 2022? If so, you may receive a letter from your orthopedic surgeon regarding the recall. If not, you should make an appointment with your doctor to discuss possible knee implant failure. They will closely monitor your knee replacement system in case you experience a device failure. If you are not experiencing persistent pain or any of the other symptoms, it is not yet necessary to undergo revision surgery.

People with defective artificial knees have two years to file knee replacement lawsuits, according to Florida’s statute of limitations. In other words, you have two years from the day your knee implant failed to file a lawsuit.

If you file an Exactech recall lawsuit, you may be able to recover the types of damages listed below.

• Medical bills associated with your original knee replacement surgery and your revision surgery.
• Physical therapy bills associated with your original knee replacement surgery and your revision surgery.
• Lost wages if your surgeries forced you to miss work.
• Loss of earning capacity if your knee pain prevents you from performing some of your normal work duties.
• Physical pain and suffering related to your surgeries.

Call the Defective Medical Device Lawyers at People for Law Today

The experienced attorneys at People For Law have been litigating defective medical device cases for more than thirty years. Our expert mass tort attorneys have also led the way in defective orthopedic implant litigation.

We have represented thousands of clients in Florida. We know the complexities of these types of devices and the failure mechanisms. More importantly, we understand the immense impact these defective devices can have on the people who receive them.

If you are in pain or have had to undergo revision knee surgery due to your Exactech knee implant, contact People For Law today. We have extensive knowledge and experience in handling knee replacement claims, so we will ensure that you receive the compensation you deserve.