We are no longer accepting new Zimmer Persona cases.
A recent voluntary recall of the porous coated, uncemented Zimmer Persona Knee Trabecular Metal Tibial Plates, which the U.S. Food and Drug Administration (FDA) subsequently categorized as a Class II recall, has led Weitz & Luxenberg, P.C., to begin accepting cases involving Zimmer Persona Knee replacement injuries, the law firm today announced.
The company that manufactures the porous coated, uncemented Zimmer Persona Knee Trabecular Metal Tibial Plate initiated its voluntary recall after learning of complaints that some of the implanted devices were losing fixation or developing radiolucencies on X-ray or both, W&L said. When a knee implant becomes loose, it can cause pain and discomfort.
Some patients are believed to have consequently found it necessary to have revision surgery performed, the law firm said, citing indications to that effect from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
“The product should not be having these problems so early in its life, which is distressing for patients,” she stated.
“Such problems can occur when companies rush implants to market without performing adequate tests and clinical trials. Unfortunately, for many hip and knee implants, to obtain FDA clearance, all they need to show is that the product is substantially similar to a device already on the market. Thus, companies often do not bother doing meaningful clinical trials to see if the device works well and safely before bringing them to market,” Relkin said.
Zimmer Persona Knee Porous Coated, Uncemented Trabecular Metal Tibial Plate Recall Draws FDA Class II Categorization
The FDA issues Class II recalls when there exists a risk that a product could cause harm, but not death or serious injury, W&L said.
“By harm, the FDA means temporary or medically reversible adverse health consequences,” Relkin clarified.
Sizes C through J of the porous coated, uncemented Zimmer Persona Knee Trabecular Metal Tibial component, both the right- and left-knee versions, are the subjects of the FDA’s Class II recall, W&L said.
Nearly 12,000 porous coated, uncemented Zimmer Persona Knee Trabecular Metal Tibial Plates had been distributed worldwide by the time of the recall, the law firm said.
Many of those units were distributed in New York, New Jersey, California and Pennsylvania, among other states said W&L. Numerous VA hospitals around the country utilized these implants. All sizes and lots of the affected devices are being removed from distribution and are being quarantined.