MT Services LLC, a Lawsuit Settlement News Reporting Company which operates lawsuitsettlementnews.com, announced today that the FDA announced a Class II recall for Zimmer's Persona Trabecular Metal Tibial Plate knee implant. The recall affects all lots and sizes of the knee implant, affecting all 11,658 devices that were recalled, according to the FDA's website. Also, according to an announcement made by the FDA, they said Zimmer Inc. initiated a voluntary recall of their Persona Trabecular Metal Tibial after there was an increase in complaints of loosening and radiolucent lines. All sizes and lots of the affected devices will be removed from the market and will no longer be distributed. A Class II Recall occurs when a product can "cause temporary or medically reversible adverse health consequences." Patients who have been implanted with the Persona Trabecular Metal Tibial Plate face the risk of their tibial component loosening. Indications of this complication include radiolucent lines on imaging tests, and such loosening may cause pain and issues with mobility, often requiring the patient to have an additional surgery.
Prior to this latest Class II Recall, Zimmer Inc. issued voluntary recalls for its metal-on-metal hip device – the Durom Cup, in 2008 – and another recall for the NexGen MIS Tibial Components in 2010. Those recalls led to lawsuits which are pending in a federal multidistrict litigation (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).
Chris Janish, CEO of MTS, commented on the recent Zimmer Class II Recall, "We are not surprised to see another voluntary recall on another Zimmer knee product. The current product has only had roughly 11K implants in the U.S., however, reports from our knee recall attorneys close to the litigation are that this product has an extremely high failure rate and could be the subject of thousands of filed lawsuit claims."