Exactech Knee Implant Lawsuit Alleges Packaging Defect Caused Polyethylene Insert to Degrade, Fail

Defective vacuum bags allowed oxygen to infiltrate and degrade the polyethylene inserts, resulting in a Exactech knee implant recall for components used since 2004

Vacuum sealed bags used for polytehylene inserts in the Exactech Optetrak knee replacement system were defective and caused the plastic liner to prematurely degrade and fail after it was implanted in the body, according to allegations raised in a product liability lawsuit recently filed against the manufacturer.

Lawrence Daly filed the complaint (PDF) last week in the U.S. District Court for the Eastern District of New York, indicating that his Exactech knee implant failed within only 10 years, due to packaging defects that impacted more than 140,000 knee replacements throughout the United States since at least 2004.

The lawsuit comes in the wake of an Exactech knee recall issued in February, after the manufacturer acknowledged that polyethylene liners in the Optetrak, Optetrak Logic and Truliant knee systems were packaged in “out-of-specification” vacuum bags, which exposed the plastic component to oxygen before it was implanted. This packaging defect increases the risk that knee implant may degrade and fail once in the body, resulting in bone loss, loosening, debris production, component cracking and ultimately the need for premature knee revision surgery.

Daly indicates he received one of the recalled Exactech knee implants during a bilateral knee replacement surgery in October 2011. According to the lawsuit, he developed severe pain in his left knee and underwent revision surgery to remove the implant in March 2021, which resulted from premature polyethylene wear of the tibial insert. He also indicates his right knee is now failing as well, and will require revision surgery in the future.

Although most patients are just now receiving Exactech recall letters about the problems, Daly indicates that the manufacturer began receiving complaints about problems with the knee implants years before the recall; as early as 2013.

“Despite Defendants’ knowledge of early onset failures of the Optetrak Device, Defendants continued to manufacture, promote, and distribute the Optetrak Device without alerting surgeons or patients of the potential increased risks of early onset failures of the Optetrak Device,” Daly’s lawsuit states. “Defendants never changed the labeling, marketing materials or product inserts to adequately and accurately warn patients or physicians of the associated increased risks of early failure due to loosening and/or polyethylene wear.”

Exactech Optetrak Knee Replacement Problems

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