Exactech Knee Lawsuit Filed Over Premature Failure of Optetrak Implant

According to allegations raised in a recently filed product liability lawsuit, problems with the Exactech Optetrak knee replacement caused a Texas man to suffer premature failure of the implant, resulting in need for revision surgery only a few years after the device was placed in his body.

The complaint (PDF) was filed by Anthony Palumbo, Jr. in the U.S. District Court for the Northern District of Texas on August 6, indicating that the Exactech knee implant was defectively designed and unreasonably designed.

Palumbo indicates he underwent total knee arthroplasty (TKA) in March 2011, at which time he was implanted with the Optetrak CR Slope and tibial tray. However, the complaint indicates the knee implant failed, which resulted in loosening, the device moving out of position, instability, limited mobility, pain and swelling.

“As a foreseeable, direct, and proximate consequence of Defendants’ actions, omissions, and misrepresentations, Plaintiff suffered a painful knee revision surgery wherein he had severe complications and was admitted to the Intensive Care Unit at Baylor University Medical Center for angioedema and was intubated – nearly dying,” the lawsuit states. “The angioedema and intubation is a direct result of Defendants’ Defective Device and the necessary revision surgery.”

The case joins a number of similar Exactech Opetetrak knee replacement lawsuits filed throughout the federal court system, each raising similar allegations that the manufacturer knew or should have known about the risk of problems, yet continued to make and sell the device for implantation into consumers.

As early as 2012, researchers published a study in Orthopaedics and Traumatology that warned of potential failures after just 25 months. In 2016, an Australian joint registry warned of higher than usual failure rates after just three years, and tied with another implant for the worst failure rate, 6.6%, after just five years. At seven years, the Optetrak had the worst failure rate of any implant on the market in 2016, with a mean failure rate of 7.9%.

According to the complaint, problems with Exactech Optetrak knee appear to be related to the use of a finned tibial trays. Although adverse event reports have been filed with the FDA for years, lawsuits indicate that instead of issuing a warning to customers or facing the bad press of a full Exactech Optetrak recall, the manufacturer engaged in a “silent recall,” by slowly replacing the finned tibial trays with a sturdier design it calls “fit” tibial trays.