Optetrak Logic Total Knee System Failure Lawsuit Filed After Revision Surgery Led to Another Optetrak Implant

Exactech faces a product liability lawsuit over the failure of an Optetrak Logic Total Knee Replacement, which caused a woman to suffer a severe infection and undergo an early revision surgery. However, since the manufacturer shipped thousands of devices with improperly packaged components, her doctors replaced the implant with another Optetrak knee, which now faces the same risk of premature failure.

Minerva Salazar filed the complaint (PDF) last week in the U.S. District Court for the Southern District of Texas, pointing out that Exactech now admits that premature and frequent failures with the Optetrak Logic Total Knee are often the result of a defectively packaged polyethylene inserts, which were exposed to oxygen before they were implanted, causing oxidization and an accelerated rate of deterioration.

An Exactech recall was issued by the manufacturer in February 2022, impacting more than 140,000 polyethylene inserts included with Optetrak, Optetrak Logic and Truliant total knee replacement systems distributed since 2004. However, thousands of individuals who received an Exactech knee replacement prior to the recall are experiencing problems where their artificial knee fails sooner and more often than others on the market.

Salazar joins a growing number of plaintiffs pursuing Exactech knee replacement lawsuits, alleging that their lives have been negatively effected when the implants failed prematurely, and claiming that the manufacturer withheld critical safety information for years about the problems associated with its Optetrak implants.

Salazar, from Texas, indicates she was implanted with the Optetrak Logic Total Knee System in July 2017. According to the complaint, that implant failed prematurely and led to her suffering a severe infection and the need for revision surgery. However, since problems with the Exactech knee still has not been disclosed by the manufacturer, her doctor replaced the implant with another Optetrak knee system with the same tibial insert that is prone to failure.

She underwent more than a month at a nursing facility during her recovery from the revision surgery and receiving the new implant. She now worries that this most recent implant may also fail prematurely.

“Exactech admits many of these premature and frequent failures are due to the improper packaging of a component part—the polyethylene insert—which exposes the part to oxygen, causing it to oxidize, and ultimately to deteriorate at an accelerated rate. This eventually leads to premature failure of the entire knee or ankle system and/or other injuries and damages,” the lawsuit states. “Because of Exactech’s wrongful acts and omissions, including its inadequate packaging of this component part, thousands of patients implanted with Optetrak, Truliant, and Vantage Systems have had to undergo (or likely will have to undergo) significant revision surgeries to remove and replace the defective devices.”

At least as early as 2017, lawsuits over Exactech knee implants indicated there were alarming rates of adverse event reports being submitted to the FDA involving premature knee replacement revision surgery, which resulted in what some said was a “silent” Exactech 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 foreign registries have found a higher-than-expected rate of Exactech knee revision surgery caused by a degraded poly liner.

As individuals continue to experience problems and require Exactech knee replacement revision surgery in the future, it is expected that thousands of similar lawsuits will be filed throughout the U.S. Court system.

October 2022 Exactech Knee Lawsuit Update

Given similar questions of fact and law raised in Exactech knee lawsuits filed throughout the federal court system, a motion has been filed to centralize and consolidate the litigation before one judge for coordinated pretrial proceedings.

On September 29, 2022, the U.S. Judicial Panel on Multidistrict Litigation heard oral arguments on the request, and will determine which venue is the most appropriate for the coordinated discovery and management of the cases.

At the time of the hearing, there were at least 27 Exactech knee lawsuits pending in 11 different federal district courts. However, as knee replacement lawyers continue to investigate and file claims in the coming months and years, it is widely expected that the size and scope of the litigation will eventually include several thousand complaints.