Millions of Americans have undergone knee, hip, or ankle replacement surgery. The surgery and recovery can be difficult and often prolonged, but the prognosis is generally good. According to the Hospital for Special Surgery (HSS), 95% of hip replacement patients experienced relief from pain. The success rate was 90-95% 10 years after surgery and 80-85% after 20 years.
Unfortunately, many patients with Exactech implants aren’t seeing that type of success–and many others are experiencing implant failures or need replacement surgery to address the failures of the Exactech implant.
What’s Wrong with Exactech Implants?
Some patients who have Exactech implants have experienced premature failure of the implant. The breakdown of the implants has caused symptoms such as:
- Pain when walking
- Stiffness/reduced range of motion
- Reduced ability to bear weight
- Clicking or grinding noises when walking
What’s causing the implants to break down? The problem isn’t a manufacturing defect or an issue with the materials used in production. Instead, the breakdown of the products was caused by a flaw in packaging. The company reported that approximately 80% of the devices manufactured since 2004 had been packaged in “out of specification” vacuum bags. The packaging was “oxygen resistant,” but did not include a second barrier layer to prevent oxygen diffusion.
That may not sound like a serious problem, but the type of polyethylene used to manufacture the implants oxidizes with exposure to oxygen, which can lead to premature breakdown of the material.
What does that mean for the patient? According to Exactech, that breakdown may result in “both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”
How Many Patients are Impacted by the Exactech Recall?
Exactech has expanded the recall multiple times since the problem was first discovered in 2021. Nearly 200,000 devices are now included in the recall. These include devices that have already had to be replaced, devices that may currently be breaking down and causing symptoms in patients, and devices that haven’t yet given signs of trouble but are at risk of premature failure.
How Do I Know Whether My Exactech Implant Has Been Recalled?
The recall extends to a great many implants, marketed under several different brand names. These include a variety of models of:
- Optetrak Tibial Components
- Optetrak Tibial Inserts
- Arthrofocus Tibial Inserts
- Truliant Tibial Inserts
- Vantage Line Components
- Acumatch Acetabular Liners
- MCS GXL Acetabular Liners
- Novation GXL Acetabular Liners
- Exactech Acetabular Cups
- Acumatch Conventional UHMWPE
- MCS Conventional UHMWPE
Exactech Litigation Updates
As of January 2023, more than 100 patients around the country have filed federal lawsuits against the company. The federal claims have been consolidated in multidistrict litigation in the U.S. District Court for the Eastern District of New York. Although these and future cases in federal court will be heard in a single court, this is not a class action lawsuit. Rather, multidistrict litigation is a way of efficiently managing many different similar claims.
Some pre-trial issues and discovery will be streamlined, and the presiding judge will have an opportunity to get up to speed on the medical and technical issues involved in the case. Then, a few cases–called bellwether cases–will be selected to try first. The bellwether cases give both plaintiffs and defendants an opportunity to learn more about what to expect, including how juries respond to the claims. That information can help expedite settlement of other claims.
The MDL is in the very early stages and no trial dates have been set.
Many claims have also been filed in state court. In Florida, dozens of cases have been consolidated in the Alachua County Circuit Court. The first trial in the Florida consolidated action has been set for November 6, 2023.
Pursuing a Claim for Exactech Implant Failure
If you have or had one of the recalled Exactech implants and have undergone replacement surgery or need replacement surgery because the implant was defective, you may be entitled to compensation.
Medical device claims are complicated–so complicated that in an MDL of this type, the court typically holds one or more “science days” to educate the judge about the terminology and medical/technical/scientific issues in the case. It’s important to work with a law firm that has knowledge of complex litigation, experience in handling technical medical cases, and access to the right experts.
At Plevin & Gallucci, we have extensive experience with complex litigation involving medical issues, including our recent representation of several bellwether plaintiffs in the National Opioid Litigation. To learn more about your rights and how we can help, just call 855-4PLEVIN or fill out the contact form on this site.
Exactech Litigation FAQs
Exactech’s payment for replacement costs ignores what the victims of their failure are entitled to. While they did offer to pay out-of-pocket expenses for patients who required replacement surgery due to the defective implants, this ignores the impact on a patient who must undergo a second surgery to replace a knee, hip, or ankle implant. Some examples of the negative consequences of Exactech’s failures include lost work time, lost quality of life during recovery, overall impact on the patient, and the unnecessary pain and suffering due to the device breakdown and subsequent treatment.
As of early 2023, the Exactech litigation is in very early stages, in both state and federal court. The first trial in the Florida consolidated case is scheduled for November of 2023, while no trial dates have been set in the federal MDL. Though we don’t yet know what those verdicts and settlements will be, an experienced defective medical device attorney like Plevin & Gallucci can explain what types of damages may be available based on the specifics of your case.
If you have one of the implants that has been recalled, you may have received a letter from your medical provider. However, you shouldn’t assume that all is well if you didn’t receive a letter. You can check on whether your specific type of implant has been recalled on the Exactech website, or check with your doctor.
If you received a letter from your healthcare provider letting you know that your device has been recalled, contact counsel immediately to understand the steps YOU must ensure are taken to protect YOU. Merely having a recalled device previously implanted likely will not be sufficient for you to assert your claim. Rather, you must take the necessary steps to make sure the recalled device is properly preserved to that your legal rights are protected.
When Should I Talk to a Defective Medical Device Attorney About an Exactech Claim?
If you have already had your Exactech implant replaced due to premature deterioration, are having symptoms that indicate your implant is failing, have been advised by your doctor that you need to have the implant replaced, or believe that you may have had a recalled device previously implanted, it is important for you to learn more about your rights. You can start right now by calling 855-4PLEVIN.