Exactech Optetrak Knee Revision Surgery Required Long Before Joint Replacement Life Expectancy: Lawsuit

A defective polyethylene tibial insert failed in two Exactech knee replacements, which has already resulted in knee revision surgery on one side, and will require removal of the implant on the other side this summer

A Delaware man indicates in a recently filed lawsuit that dangerous design and manufacturing defects caused him to require knee revision surgery for his Exactech Optetrak knee replacements prematurely, after the a defective polyethylene insert degraded and wore out long before the expected life-expectancy for the artificial joint.

The complaint (PDF) was filed by Rex A. Foxwell, and his spouse, Lee, in the U.S. District Court for the District of Maryland on April 26, pursuing product liability claims against Exactech, Inc., as the defendant.

In February, an Exactech knee recall was issued for more than 140,000 Optetrak, Optetrak Logic and Truliant implants distributed since 2004, which were packaged in “out-of-specification” vacuum bags that exposed the plastic components to oxygen before they were implanted. The manufacturer acknowledged at that time that the packaging defect increased the risk the knee implant may degrade and fail once in the body.

According to the lawsuit, Foxwell received an Optetrak knee replacement system, including an Optetrak Logic tibial insert made of polyethylene, in December 2010 for his left knee. He underwent a similar procedure on his right knee in April 2011. However, over the years Foxwell began to suffer stiffness, discomfort and pain in both joints, as well as swelling around both knees which extended into his lower legs.

By November 2021, Foxwell’s surgeon determined the Optetrak system in his left knee had failed, and removed it through revision surgery. The surgeon discovered polyethylene wear, osteolysis and loosening of the implant.

Now, the lawsuit notes, the same conditions are affecting Foxwell’s right knee as it has begun to fail as well.

“As stated above, the pain and instability in Rex A. Foxwell’s right knee have continued to increase in severity,” the lawsuit states. “As a result, Plaintiff will also require surgery to revise the TKA in his right knee. The revision surgery for Plaintiff’s right knee is presently scheduled to occur on June 2, 2022.”

The knee replacement lawsuit claims the Optetrak knee systems were defective in design, manufacturing and the materials used, and that the problems suffered by Foxwell, and other Optetrak knee implant recipients, were foreseeable and avoidable.

Exactech Optetrak Knee Replacement Problems

The case joins a growing number of Exactech knee lawsuits now being filed by individuals who experienced 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 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.