Exactech introduced the Optetrak Knee Replacement in 1994. However, a growing number of lawsuits allege that certain versions are defective and prone to premature device failure.
Knee replacement surgery is becoming a popular option for patients suffering from chronic knee pain and disability due to arthritis, severe injury or excess wear and tear on their body.
Currently, around 700,000 knee replacement surgeries are performed annually in the United States. By 2030, that number is expected to hit 3.48 million per year.
The first Optetrak Knee Replacement was approved by the U.S. Food & Drug Administration (FDA) in 1994. Since then, various other versions have been brought to market via the agency’s 510(k) program, which allows a device to gain regulatory clearance without the benefit of human clinical trials when a manufacturer can demonstrate that the new product is “substantially equivalent” to a device that has already been subjected to the FDA’s stringent premarket approval process.
If all goes well, a knee replacement should last at least 15 years.
However, a growing number of Optetrak Knee Replacement lawsuit filings allege that versions of the system manufactured in 2011 and 2012 are prone to early failure. These models featured a “finned” tibial tray, which purportedly fails to promote adequate adherence to surgical cement.
Plaintiffs who have filed Optetrak Knee lawsuits claim that the FDA’s adverse event database has received multiple reports of premature failures since 2011. In many of these cases, patients were forced to undergo risky revision surgery to remove and replace the device.
Plaintiffs further allege that the growing number of problems associated with the finned tibial tray ultimately forced Exactech to conduct a “silent recall”, at which time those components were replaced with a “fitted” tibial tray that would result in better patient outcomes.
“The fact that Exactech made this “silent recall” device replacement indicates the company knew – or should have known – about the failures of their Optetrak knee replacement product, and that it was not safe for patients,” the complaints state.
In 2012, a study published in Orthopaedics & Traumatology: Surgery & Research investigated outcomes among 110 Optetrak Knee Replacement patients at 25 months post-op.
The authors of the study discovered that tibial loosening was occurring at the cement-tibial-implant component of the device, resulting in fragmentation, device wear, chronic pain, disability and other serious complications.
“This tibial implant with a small keel does not resist the stresses applied by posterior stabilization, with notably a higher level of stress than the Insall prosthesis from which it was derived,” they concluded. “In cases of centering defect, the design of the trochlea can lead to impingement between the edges of the patella and the prominent edges of the prosthetic trochlea. We have suspended implantation of this prosthesis and continue to monitor the progression of patients having received these implants.”
In 2016, the Australian Joint Replacement Registry reported that the Optetrak Knee had extremely high failure rates as early as three years after implantation. The 5-year failure rate was 6.6%, while the rate at 7 years was 7.9%.
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