The U.S. Food and Drug Administration (FDA) issued a notice on March 12, for a Class II recall for all lots and sizes of the Zimmer Persona® Trabecular Metal™ Tibial Plate knee implant. According to the FDA’s website, all lots and sizes are affected of the 11,658 devices that were recalled.

“Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution,” the FDA announced.

The FDA will issue a Class II Recall when a product can “cause temporary or medically reversible adverse health consequences.” However, problems associated with this Zimmer knee implant can cause serious complications and patients implanted with the Persona® Trabecular Metal™ Tibial Plate can face the risk of loosening of their tibial component. Indications of loosening include radiolucent lines on imaging tests, which are large gaps between the device and bone. Loosening can cause pain and significant mobility problems, and generally requires the patient to undergo additional surgery to remove and replace the loose tibial component.

Zimmer Inc.’s voluntary recall is the latest headline in a number of highly publicized medical device recalls. In fact, Zimmer issued a voluntary recall of its metal-on-metal hip device, the Durom® Cup, in 2008, and another recall for the NexGen® MIS™ Tibial Components in 2010. Both recalls resulted in pending lawsuits that are part of federal multidistrict litigations in New Jersey (In Re: Zimmer Durom Hip Cup Products Liability Litigation, MDL No. 2158) and Illinois (In Re: Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272).

Source: Seeger Weiss LLP