Knee Replacement Lawsuit
The knee replacement device manufacturer, Exatech, recently announced updates to its 2021 product recall. Certain devices featuring a polyethylene (plastic) insert were subject to degradation when exposed to oxygen, leading to several adverse outcomes for patients.
Patients who received one of the affected devices as an implant are now seeking damages for their losses. Many other knee replacement devices are part of similar product recalls, including certain models made by Arthrex Inc. and DePuy Synthes.
What’s the Reason for the Exatech Recall?
Exatech first announced a major recall of knee replacement products in August of 2021. More than 150,000 devices were affected by the initial recall. These knee implants must be stored and transported in an oxygen-tight, vacuum packaging.
In 2021, however, the company said it had discovered a problem with the devices’ packaging. Specifically, the vacuum bags didn’t feature a necessary secondary layer that would enhance its protection against oxygen contamination. This meant that the plastic inserts in the devices were susceptible to oxidation, which could go on to affect the inserts’ mechanical function.
Updates to the 2021 Recall
Since the first recall from Exatech, the company has announced additional updates that expand the scope of affected devices and give more detail on the extent of the defects. In February of 2022, Exatech stated that the recall would include all knee or ankle polyethylene inserts that featured insufficient packaging.
The company emphasized that this recall affects any such product, without respect for its shelf life or label. Exatech also clarified that these newly-recalled devices had likely already been received by hospitals and implanted in patients, instructing doctors to monitor affected patients.
As of April 2022, the company offered new findings on the scope of the problem. Exatech said that about 80% of the knee implant inserts released to the market since 2004 did not have sufficient packaging, and were therefore susceptible to degradation.
Issues Patients Could Face with Exatech’s Knee Replacements
These devices are used during total knee arthroplasty (TKA) procedures, which are generally intended to assist people with severe arthritis or knee deformities, offering patients relief from significant pain. However, Exatech’s recalled plastic inserts can have problems with their mechanical function. They also can produce wear debris at a more rapid rate, may be more likely to crack or fracture, and can show signs of loosening in the body. (Exatech)
For patients who are now living with recalled devices implanted through TKA, they are at risk of:
- Bone loss
- Recurring swelling in the knee
If you have a recalled implant, Exatech does not recommend a pre-emptive surgical removal. You should speak with your doctor if you are experiencing any concerning symptoms, and your doctor should continue to monitor your device and your symptoms before making further treatment recommendations. If revision surgery is advised, Exatech will provide a replacement device. The company will also pay for out-of-pocket costs associated with a recalled device.
Get Legal Help for a Defective Knee Replacement Device
A number of lawsuits have been filed against manufacturers of defective knee replacement products. If you have a recalled Exatech device or another similar product, you could seek compensation for your losses. You can fill out a contact form online to learn about your eligibility and get a consultation from a lawyer’s team.