Medical Device Manufacturer Exactech Recalls Knee, Ankle and Hip Replacement Parts
Exactech has issued a recall for thousands of the polyethylene plastic inserts that are used for its knee, ankle and hip replacement parts. The company found the plastic inserts may wear early which can lead to implant failure.
Patients that experience an implant failure will typically need revision surgery. One of the main reasons for the implant failures turned out to be out-of-specification packaging that allowed the parts to come into contact with oxygen.
As it turns out, exposure to oxygen greatly degrades the plastic inserts. Common side effects that can point to device failure may include bone loss, lysis, swelling, difficulty walking and pain at the implant site. Some of the recalled devices include:
- OPTETRAK® All-polyethylene CR Tibial Components
- OPTETRAK® All-polyethylene PS Tibial Components
- OPTETRAK® B-Series Ps Tibial Insert
- OPTETRAK® CC Tibial Inserts
- Exactech GXL polyethylene liner
A number of scientists have hypothesized that a stricter approval process can help prevent faulty medical devices from reaching the market. According to Carl Pellerin, one of the studies authors, “A larger proportion of knee arthroplasty surgical devices cleared through the 510(k) process were recalled compared to implants approved through the stricter PMA process. Changing the 510(k) process may enable manufacturers to improve upon the safety of their devices.”
There are a number of steps that patients should take if they suspect that they may have recalled implant parts from Exactech. First, patients should speak with their doctors to confirm the make and model of any implant parts.
Second, they should monitor the implant site for pain and swelling. It is also a good idea to speak with an experienced product liability attorney about the specific facts of your case.
The defective medical device attorneys at Gersowitz Libo & Korek, P.C. are here to answer any questions that you may have. They can investigate all of the unique facts of your case and let you know if you have a claim that can be pursued. You can reach out to them anytime at (516) 908-9792.