Lawsuit Alleges Exactech Knee Implant Problems Were Concealed From Patients, Doctors

Premature wear of the polyethylene tray led to knee implant problems and the need for revision surgery, according to the lawsuit, which indicates that Exactech concealed known issues for years

After experiencing problems with an Exactech knee implant, which failed only a few years after it was used during a total knee replacement, a South Carolina woman has filed a product liability lawsuit indicating the manufacturer concealed information about a known manufacturing defect from patients and doctors.

Melissa Davis filed the complaint (PDF) in the U.S. District Court for the District of South Carolina on April 15, indicating that an Exactech Optetrak knee implant placed in her body in 2017 was defective and adulterated, since its packaging was not in conformity with federal safety requirements.

The lawsuit comes only weeks after an Exactech knee recall was issued in February 2022, indicating that more than 140,000 Optetrak, Optetrak Logic and Truliant implants distributed since 2004 were packaged in “out-of-specification” vacuum bags, which exposed the plastic components to oxygen before they were implanted.

The manufacturer acknowledged at that time that the packaging defect increased the risk that the knee implant may degrade and fail once in the body, but the lawsuit filed by Davis indicates information about the Exactech knee implant problems was withheld and concealed by the manufacturer for years.

Davis indicates she underwent bilateral total knee replacement surgery in 2017, at which point she was implanted with the Optetrak knee devices. After only three years her right knee failed, resulting in the need for revision surgery.

“The surgeon noted extreme deterioration of the polyethylene tray component. The degree of deterioration resulted in a complete failure of the Defective Device, requiring total replacement,” the lawsuit states. “The components of the device were defective, unreasonably dangerous and failed, resulting in loosening, malpositioning of the implant, and rubbing/wear of the components causing instability, limited mobility, swelling and pain.”

She underwent revision surgery on the right knee in 2020. However, the lawsuit indicates Exactech knew about the defective nature of the implants since at least 2012.

“Despite [Exactech]’s claims in its promotional material of over 30 years of successful outcomes with knee devices, [Exactech] knew of an unacceptably high early failure rate of their Optetrak knee implants,” according to the lawsuit. “On information and belief, [Exactech] concealed this information while its CEO and President David Petty bragged about the strong double-digit growth in knee business. From 2012 to 2016, a time when [Exactech] should have been recalling products, Exactech’s Extremities division almost doubled in size, from $52.1 million (2012) to $100.3 million (2016).”

Davis joins a growing number of patients now pursuing an Exactech knee implant lawsuit after experiencing problems with an Optetrak, Optetrak logic or Truliant system received in recent years, indicating that the manufacturer ignored evidence of an abysmal knee failure rates associated with the implants.

As early as 2017, lawsuits over Exactech knee implants indicated there were alarming rates of adverse event reports being submitted to the FDA, which resulted in what some said was a “silent” Exactech knee recall when the company began slowly and quietly replacing the tibial trays of some Optetrak models.

In the recall notice issued earlier this year, the manufacturer acknowledges the foreign registries have found a higher-than-expected rate of Exactech knee failures involving the poly liner, often resulting in the need for additional surgery only a few years later.