Exactech Knee Implant Liner Failure Led to Revision Surgery, Lawsuit Claims

According to allegations raised in a recently filed lawsuit, a Florida woman had to undergo revision surgery and was left with permanent injuries due to an Exactech knee implant liner failure, which was caused by manufacturing defects that have since resulted in a recall for more than 140,000 components.

The complaint (PDF) was filed by Theresa M. Pagnotta in the Supreme Court of the State of New York on April 1, indicating she is one of thousands of individuals who have been, or will be, required to undergo additional surgery due to problems with the Optetrak Comprehensive Total Knee Systems manufactured by Exactech, Inc.

The lawsuit comes in the wake of an Exactech knee recall issued in February, impacting more than 140,000 Optetrak, Optetrak Logic and Truliant implants since 2004, which included a polyethylene liner that was packaged in “out-of-specification” vacuum bags, which exposed the plastic component to oxygen before it was implanted, increasing the risk of failure within a few years.

Pagnotta underwent left total knee replacement surgery in January 2013, at which time an Exactech Optetrak knee was implanted. However, only eight years later, she underwent revision surgery, after her doctor diagnosed an aseptic loosening of the implant, as well as osteolysis.

As a result of the Exactech knee implant liner failure, Pagnotta had to go through a six-hour revision surgery and was hospitalized for six days. Doctors found the femoral component of the Exactech knee implant to be “grossly loose” and the surgeon was able to pick up the femoral component off of her femur manually, which should not be possible.

Following the premature knee failure, Pagnotta has been left with significant pain, gait impairment, poor balance; difficulty walking, soft tissue damage and bone loss, according to the complaint.

The lawsuit claims the problems were caused by premature wear of the tibial insert, which Pagnotta says Exactech knew about, but did nothing to prevent.

“At all times relevant to this action, Defendants were aware of the Optetrak Device’s propensity to undergo substantial early polyethylene wear, component loosening and/or other failure causing serious complications including tissue damage, osteolysis, and other injuries as well as the need for revision surgery and its attendant complications in patients,” Pagnotta’s lawsuit states. “Nonetheless, Defendants still did not adequately warn patients, the medical community, or the public about these risks, and continued to promote, market, sell and defend the Optetrak Device until August 2021, at which point in time only a partial recall was issued.”

Exactech Optetrak Knee Lawsuits

The case joins a growing number of Exactech knee replacement lawsuits now being filed by individuals who experienced problems with an Optetrak, Optetrak logic or Truliant implant 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 now 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.