Consumer Alert: On March 12, 2015, the U.S. Food and Drug Administration (FDA) issued a notice for a Class II recall for all lots and sizes of the Zimmer Persona® Trabecular Metal™ Tibial Plate Knee Implant (prosthesis). All lots and sizes of the referenced prosthetic devices are affected, and according to the FDA, a total of 11,658 devices were recalled.
The issues and/or complaints relative to these prosthetic products include radiolucent lines affecting the bone's integrity, structure and strength, and loosening of the prosthesis.
Zimmer Inc. is initiating a voluntary recall of these medical devices, and all sizes and lots affected are being taken out of distribution.
A class II recall may be effectuated if a product can "cause temporary or medically reversible adverse health consequences." Despite that definition of a Class II recall, those affected by the deficiencies inherent in these products can sustain significant permanent injuries, especially in light of the risk of loosening of the prostheses' tibial component. A loosening prosthesis can be painful and cause a lack of mobility/impaired gait; and may be diagnosed by radiographic examination (x-rays) and clinical evaluations. Often, surgical revision is required to address the significant health issues associated with defects in knee and other joint prostheses. In this case, surgical replacement of the tibial component may be required.
Zimmer Inc. has had a number of issues with other of its joint prostheses, precipitating multiple other recalls including those for hip replacements (metal on metal prostheses), the Durom® Cup (2008), and a recall for the NexGen® MIS™ Tibial Components (2010). Prior recalls have spurred multidistrict litigation including: 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).
For additional information regarding the Zimmer Persona® Trabecular Metal™ Tibial Plate knee implant, click here.
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