Different knee replacement systems, including the Exactech Optetrak system, have been linked to severe adverse effects and complications. Other systems have included DePuy’s Synthes Attune Knee System and Athrex’s iBalance TKA Tibial Tray. Patients suffering adverse effects stemming from these systems have frequently required knee replacement revision surgery to correct the issues.
Some symptoms of faulty knee replacement systems include mobility issues, swelling, pain, infections, dissociation of implant, instability problems, fractures, inflammation, implant loosening, component position change, and patello-femoral tracking-lateral release.
Patients reporting knee replacement complications have increased along with the number of patients undergoing knee replacement surgeries. Knee replacement surgeries may be used to treat normal wear and tear of the knees, arthritis, or severe injury.
Every year, there are roughly 700,000 knee replacement surgeries are conducted. By the year 2030, it is estimated that there will be an increase of 3.48 million knee replacement surgeries every year.
A knee replacement surgery may result in increased mobility assistance and pain-free stability. However, manufacturers of knee replacement systems, such as Exactech, Arthrex, and Depuy, have announced recalls either due to manufacturing defects in design or in construction of the implant.
Exactech Optetrak
Exactech, a large medical device manufacturing company, was established in 1994. Although Exactech is well known for manufacturing knee replacement systems, the U.S. Food and Drug Administration (FDA) received reports of complaints with the Exactech Optetrak knee replacement device starting in 2011. Allegedly, the premature failure of the device was caused by the wear and tear of the tibial insert.
The Exactech Optetrak knee replacement system is also among many devices approved by the FDA’s “fast-track” approval process. Known as the 510(k) process, it allows companies to bring manufactured devices to market faster, often bypassing thorough testing.
For more than 30 years, Exactech has been manufacturing knee replacement systems. What was different about the Exactech Optetrak system was that it contained a “finned” tibial tray. This tray, however, was reportedly found to not sufficiently adhere to surgical cement and in September of 2011, a Class 2 recall was announced.
According to the FDA’s announcement, all affected customers were instructed to “immediately cease distribution or use of the products.”
A different version of the Exactech Optetrank system that included a “fit” tibial tray was made available in 2013, promising better long-term results. This was in contrast to the previous “finned” tibial tray.
Exactech Optetrak Knee Replacement Lawsuit
Patients allege that the company knew the knee system was susceptible to early device failure and adverse effects. Plaintiffs filing knee replacement lawsuits allege that the Exactech Optetrank is a dangerous and defective device that causes irreversible damage.
Other allegations include that the company did not sufficiently test the knee replacement system before putting it on the market and that the company did not conduct thorough lab tests to check for adverse effects. Patients also say that the company failed to conduct sufficient follow-up tests or adequate post-market tests.
If you feel like you have suffered adverse effects such as from infection, fracture, or swelling, and was implanted with a knee replacement device, you may be eligible to file an Exactech Optetrank knee replacement lawsuit.
Get a Free Knee Replacement Case Review
If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.
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