Optetrak TKA patients have been suing Exactech over poly failure from an alleged packaging issue.

This is one to watch for the whole ortho industry. There have been numerous lawsuits filed against Exactech, the manufacturer of the Optetrak knee implant, alleging that the device is defective and can cause a variety of problems, including pain, swelling, instability, and failure. The first lawsuit against Exactech was filed in 2017, and since then, there have been hundreds of additional lawsuits filed. The lawsuits allege that the Optetrak knee implant is defective because it contains a plastic insert that can wear down and break over time. When the insert breaks, it can release metal particles into the joint, which can cause inflammation, pain, and other problems. In 2019, Exactech issued a recall of all Optetrak knee implants manufactured before August 2016. The company advised patients who have received an Optetrak knee implant to consult with their surgeon to determine whether the implant needs to be replaced. In addition to the lawsuits, the U.S. Food and Drug Administration (FDA) is also investigating the Optetrak knee implant. In 2020, the FDA issued a warning letter to Exactech, stating that the company had failed to provide adequate information about the risks associated...


Unlock the full article and exclusive OrthoStreams insights: in-depth analyses, hot startups, trends, market intel, and Daily Newsletter—for just $1/day.
Subscribe Now—Up your Game !
 

Scroll to Top