Reports are being made to the U.S. Food and Drug Administration (FDA) regarding failures of Exactech Optetrak knee components due to tibial insert wear and tear of the knee replacement.
Total Knee Replacement Surgery
Total knee replacement, the most common type of joint replacement, involves resurfacing the damaged bone and cartilage of the knee joint. During knee replacement surgery, the joint is exposed by an incision made down the center or off to the side of the knee. The damaged portion of the femur, tibia, and the patella is then removed and replaced with metal and/or plastic components that are intended to replicate the knee’s natural movement and function.
Symptoms of a Failing Knee Replacement
Although knee replacement surgery can be a life-changing procedure for those suffering from chronic arthritis, when prosthetic components begin to fail, a variety of symptoms can occur, including:
• Pain, ranging from mild soreness to severe in nature
• Mobility problems
• Swelling that stimulates the production of fluid in response to the irritation
• Instability caused by the loosening of the joint
• Noticeable warmth of the joint
The warmth associated with prosthetic failure is often significant and accompanied by redness of the skin caused by the inflammation.
Why Do Knee Replacements Fail?
While many knee replacements function well for many years, some will fail. Knee replacement failures can occur for a number of reasons, including:
• Wear and tear with subsequent loosening of the implant
Sometimes knee replacement failure is the result of a defectively designed component, such as when wear of the polyethylene insert results in fragmentation and wear, most notably of the posterior lip on the medial side. Examples of tibial insert wear that have been reported to the FDA can be found by searching the agency’s MAUDE database.