Exactech’s hip and ankle replacement devices are subject to failure at a rate that necessitated the Florida-based company to issue recalls for both their knee and ankle devices.
According to Drugwatch, “Recalled Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts fit in between metal components in knee and ankle replacements to cushion joints. The recall affects tibial inserts and liner components from the following knee and ankle replacement systems: Optetrak, Optetrak Logic, Truliant and Vantage.
Exactech recalled the devices because of out-of-specification packaging that didn’t adequately protect the inserts from oxygen exposure, according to the company’s Urgent Medical Device Correction letter sent to surgeons on February 7, 2022. Exposure to oxygen can cause the inserts to degrade over time and lead to early device failure.” According to Exactech, the company’s recall of more than 147,000 knee and ankle devices was based on non-conforming packaging that failed to protect the devices from early exposure to oxygen. Evidently, the company’s knee and ankle implants are packaged in vacuum-sealed bags that are designed to protect the device. However, the company acknowledges that “most of our inserts manufactured since 2004 were packaged in out-of-specification … vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.”
Like their hip liner, the Exactech ankle and knee replacement devices may lead to bone loss, accelerated wear, debris production which can migrate into other areas of the body, component fatigue and component cracking or fracture that will require revision surgery to correct.
According to the FDA, this is a Class 2 recall which means that the failed devices may cause temporary but reversible injury.
The Optetrak Knee device has been on the market since 1992 and Exactech claims the packaging problems originated in 2004. Data from Australian, New Zealand and United Kingdom registries have shown the implant has significantly higher overall revision rates compared to other knee implants, according to the company’s recall letter.
The Optetrak Knee has been the subject of numerous lawsuits prior to this recall and due to premature failure, pain, and instability.
If you or a loved one has had one of the recalled Exactech knee or ankle devices implanted, contact your surgeon immediately.
At Rheingold Giuffra Ruffo Plotkin & Hellman we have decades of experience representing clients who have suffered as a result of failed medical devices such as defective hips, ankles, and knees. Contact us for a free case evaluation.
Our lawyers at Rheingold Giuffra Ruffo Plotkin & Hellman LLP understand this and have had decades of experience holding medical device manufacturers responsible for defective products. For help, contact us online or by dialing (212) 684-1880.
If you’ve experienced complications after receiving an Exactech device, you may be entitled to pursue a defective product claim. Those harmed by defective medical devices have the legal right to seek compensation for damages, including lost wages, medical expenses (past, present, and future), and pain and suffering.
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