A woman has filed a lawsuit against medical device company Exactech after suffering from physical injury related to a knee replacement failure.

Plaintiff Vicky W. filed her Exactech Optetrak lawsuit in Alabama federal court. She claims the Optetrak is a defective device that, in particular, has an increased risk of failure for patients who are overweight or obese.

“As a result of the defective nature of the Optetrak knee replacement procedure, persons who were implanted with a Defective Device, including Plaintiff, have suffered, and may continue to suffer, severe and permanent personal injuries, including painful knee revision surgery to remove or revise the Defective Device, continued rehabilitation, medical care, and possible additional surgeries,” the Exactech Optetrak lawsuit states.

After she had the implant placed, Vicki states that she experienced pain and other symptoms that required her to undergo a revision surgery to remove the allegedly defective device. She had it replaced with a different knee replacement system, according to the Exactech Optetrak lawsuit.

The Exactech Optetrak knee replacement system was initially released to the market in 1994. According to the Exactech Optetrak lawsuit, the company became aware of the high rate of early failures with the knee implants as far back as April 2008. At that time, the company began designing a new tibial tray for the device in hopes that it would have corrected some of the issues that have been reported about the device.

“Despite actual knowledge of the increased risk of failure related to the defective nature of the Optetrak knee implant design, Defendants made the decision not to recall, stop selling, or otherwise change the warnings for the affected devices until there was a suitable replacement approved for the U.S. market,” the Exactech Optetrak lawsuit states.

Additionally, the Exactech Optetrak lawsuit says increased failure rates were observed in overweight and obese patients in April 2008. In 2012, the complaint states that Exactech had additional information from clinical evidence about the failure rates of the knee replacement system being higher than expected.

The complaint states that instead of warning consumers about the increased failure rates associated with the device, the company chose to engage in a so-called “silent recall” campaign “where it slowly replaced all finned tibial trays with a new, more substantial design, referred to as ’fit’ trays.” The Exactech Optetrak lawsuit states that rather than acknowledging any potential product defects, the company blamed early failure on “surgeon specific factors instead of admitting to any issues with the finned product itself.”

As a result, Vicky has raised counts of negligence, violation of Alabama Deceptive Trade Practices Act, Alabama Extended Manufacturers’ Liability Doctrine, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, breach of express warranty, breach of implied warranty and fraud.

The plaintiff is seeking general damages, medical, incidental and hospital expenses, pre-and post-judgment interest, consequential damages, compensatory damages, punitive damages, attorneys’ fees and costs and any additional relief as deemed just and proper by the court.

The Exactech Optetrak Lawsuit is Case No. 2:17-cv-01493-AKK, in the U.S. District Court for the Northern District of Alabama, Southern Division.

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