Warsaw, INAs we slip past the one-year anniversary of the Zimmer Persona Recall, the manufacturer of the failed Persona Trabecular Plate has selected a second bellwether lawsuit for its troubled NexGen knee as litigation mounts over knee implants across various product lines.
According to court documents, Anthony Reaves suffered what the plaintiff describes as “unbearable pain” following what was thought to be a routine knee replacement procedure in 2007. While the lawsuit, originally filed in 2012 involves the NexGen knee implant, plaintiffs experiencing Zimmer Persona Knee pain from the problematic Trabecular plate are facing challenges similar to those experienced by Reaves, who is suing Zimmer, Inc., Zimmer Holdings, Inc., Wilson/Phillips Holdings, Inc., and Zimmer Inc. (Reaves v. Zimmer et al, Case No. 2:2012-cv-10539, in Michigan Eastern District Court).
It was last March that the US Food and Drug Administration (FDA) issued a Class II recall of the Zimmer Trabecular Metal Tibial Plate following a voluntary recall of the component by Zimmer the month prior. The FDA’s Class II recall “seals the deal,” as it were, for the recall.
The Zimmer Persona Personalized Knee System is a complex system designed to provide the knee replacement patient with a better fit over the long term, and is intended to allow for a more active lifestyle than previous generations. It also presumes that today’s middle-aged Americans - or those just now easing into retirement - have been more active over their respective lifetimes and thus have joints such as knees and hips presenting with a greater degree of wear and tear. Hence, the need for medical devices such as artificial knees and hips at perhaps a younger age.
With that in mind, manufacturers have been busy updating their systems in an effort to deliver a longer-lasting product that would support a more active lifestyle. However, in practice, the opposite has held true, with artificial knees or their respective components failing to meet the outer limits of the 15-year historic lifespan of first-generation devices. Some patients have found that their artificial knees have failed within 18 months of installation.
Many of these patients have required revision surgery that is often more complex - and requiring for some a longer convalescence - than the initial procedure.
It should be noted that only the Trabecular Metal Tibial Plate was subject to the Zimmer Persona Recall. The remaining aspects of the Zimmer Persona Personalized knee system have not been subject to recall.
“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, on March 12 of last year.
Some 11,658 devices were, indeed, removed from the market. Others have been removed from plaintiffs and patients. There are those, however, whose knee implants are functioning normally for now - but are nonetheless waiting for the other shoe, or knee, to drop…
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