Exactech® Knee Litigation Attorneys Serving Nationwide
Hundreds of thousands of patients have been implanted with Exactech Knee replacements systems since the devices were first introduced to the market. However, many of these systems have dangerous design defects which prompted the companies and the Food and Drug Administration (FDA) to issue warnings and for Exactech to recall the potentially dangerous products, including the Exactech Optetrak, Truliant and Logic Knee replacement systems. Thousands of patients have experienced complicated problems, including component fatigue and breakdown, bone loss and cracking, and accelerated knee wear, causing early painful revision surgery to correct the problems.
Defective polyethylene inserts, which are utilized in knee replacement surgeries are wearing out and degrading prematurely, resulting in necessary knee revision surgeries. In February 2022, Exactech issued a recall for more than 147,000 knee, ankle and hip implants used since 2004. The FDA has also issued recalls after receiving numerous reports of knee implant failures.
Symptoms that Your Knee Replacement Is Failing
Symptoms of replacement knee failure caused by premature wear of the polyethylene insert may cause: New or worsening knee pain, knee swelling, pain while walking, knee instability, grinding, clicking, or other noises from the knee implant. If you are suffering from these, then you should immediately report the issue to your surgeon, who will likely perform an examination and obtain knee x-rays to evaluate the device. If it is found that you are experiencing problems or replacement knee failure, your surgeon may recommend knee revision surgery to remove or replace the components. An alternative to removal of the knee replacement may include surgery to exchange the defective polyethylene insert.
Even if you or a loved one have not experienced symptoms, knee recall settlements may still be available. The recalled knee replacement will likely result in the need for additional medical monitoring and treatment, and possibly a revision surgery to remove the defective liner.
On February 7, 2022, an Exactech knee replacement recall notice was sent to orthopedic surgeons throughout the United States, providing information about over 100,000 defective and dangerous knee inserts implanted in patients starting in 2004. The manufacturer also provided this recall letter that should be sent to all individuals who had the defective device impacted. Although most consumers didn’t learn about this recall until 2022, the manufacturer first disclosed problems with the replacement inserts in an August 2021 recall to over 60,000 patients. The recall has now been substantially expanded to include Exactech Optetrak knee replacements sold since 2004, Logic knee implants sold since 2009, and Truliant knee systems sold since 2017.
Originally introduced in the United States in 1994, the manufacturer’s implant was on the market for about ten years before any significant changes were introduced. These changes were made to the manufacturing process for vacuum bags used for polyethylene inserts with these knee implants, which is the reason for the extensive recall.
Most of this manufacturers knee implants sold since 2004 have been recalled, including:
Exactech Optetrak CR Tibial Components
Exactech Optetrak PS Tibial Components
Exactech Optetrak CR Tibial Inserts
Exactech Optetrak CR Slope Tibial Inserts
Exactech Optetrak PS Tibial Inserts
Exactech Optetrak HI-FLEX PS Tibial Inserts
Exactech Optetrak Logic CR Tibial Inserts
Exactech Optetrak Logic CR Slope Tibial Inserts
Exactech Optetrak Logic CRC Tibial Inserts
Exactech Optetrak Logic PS Tibial Inserts
Exactech Optetrak Logic PSC Tibial Inserts
Exactech Optetrak Logic CC Tibial Inserts
Exactech Truliant CR Tibial Insert
Exactech Truliant CR Slope Tibial Insert
Exactech Truliant CRC Tibial Inserts
Exactech Truliant PS Tibial Inserts
Exactech Truliant PSC Tibial Inserts
What Is the Problem with Exactech Optetrak Knee Implants?
Anyone who received the now recalled knee implant may face an increased risk of experiencing problems with their Exactech knee replacement. This may result in the need for revision surgery after experiencing symptoms of additional knee problems. A total knee replacement system includes a number of specific components, which all work together to provide an artificial knee replacement. These include the femoral implant, tibial tray, patellar component, and a tibial polyethylene insert. The problem with the Exactech recalled knee implants is found in the polyethylene insert, which serves a very important function throughout the life of the knee replacement. The polyethylene or plastic knee insert is a “shock absorber” and replaces the function of cartilage in your knee joint. If the plastic insert fails, the knee replacement fails.
Officially known as an Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) knee insert, the knee replacement liners were found to be packaged in defective vacuum bags that were not sufficiently oxygen resistant. These insert bags did not contain a second barrier layer containing ethylene vinyl alcohol, which is intended to protect the knee insert from prematurely degenerating. This can cause oxygen to reach the plastic inserts during storage or before it is implanted, resulting in oxidation that severely degrades the polyethylene liner. This increases the risk of several knee replacement problems much earlier than expected, including:
Accelerated knee wear
Component cracking, fracture or fatigue
Additional knee revision surgery
If you or a loved one has been injured by an Exactech knee replacement system, contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation to discuss your legal rights. Contact us.