Exactech knee replacement devices are subject to multiple problems leading to premature failure, according to orthopedic surgeons who conducted a study of the devices at a French teaching hospital.

Specifically, the study focused on the Exactech Optetrak, which the researchers found were subject to tibial loosening and patellofemoral instability. In simple terms, the knee prosthesis does not stay in place.

The result is chronic pain, reduced range of motion and in many cases, toxicity from the metals and cement used during the implantation. Patients who experience knee replacement failures of this nature typically require revision surgery and may wind up suffering long-term disability.

The Exactech Knee Story

Since 1994, Exactech has dominated the world market for medical devices, specializing in artificial joints. The Optetrak has been its flagship product; however, since approving the device, the FDA began receiving numerous adverse event reports of premature device failure and other complications.

Under normal circumstances, 90 percent of all knee replacements are good for 20 years or more. This has not been the case with the Optetrak series, however. Patients have complained about the device falling out of alignment, instability and reduced range of motion in addition to pain and other symptoms.

What Went Wrong, And Why

Problems with the Optetrak knee prosthesis were traced to a design feature. Even a healthy, natural knee joint is the hardest-working joint in the body; therefore, a prosthesis must be carefully engineered to bear the load. This is where Optetrak designers allegedly failed.

Specifically, it was a finned tibial tray (the component attached to the top of the shin bone), which apparently was not able to withstand the normal stress that is placed on the knee joint. Furthermore, this finned design often did not adhere well to the surgical cement used during the procedure to fix the device in place.

In August 2011, a Class 2 recall was issued for these Exactech knee devices.

“Premarket Notification” Strikes Again

Exactech knee lawsuits that have been filed claim that the Optetrak was never subject to rigorous testing. Furthermore, the manufacturer stands accused of failing to carry out post-marketing and follow up studies.

Plaintiffs in these actions have powerful evidence to support these claims. As is the case for so many problematic medical devices, the Optetrak was approved by way of the FDA’s “fast track” process, known as 510(k) Pre-Market Notification. Essentially, Exactech told the FDA that its Optetrak prosthesis was “substantially equivalent” to a device that was already on the market.

This “fast track” approval allows medical device manufacturers to bypass normally rigorous (and more importantly, expensive) testing requirements. The application fee is also much lower. While there may have been good intentions behind Pre-Market Notification, the result has been a large number of defective devices being used on patients, who experience serious injuries as a result.

20 Percent Failure Rate?

According to the aforementioned French study, more than 20 percent of patients reported various signs of device failure within a little over 2 years of receiving the device. Over 12 percent of the patients required revision surgery.

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