Pundits find it remarkable that while the life expectancy of Americans continues to rise - thanks in part to ongoing advancements in modern medicine, disease prevention and more active lifestyles - the quality of the “parts” employed to make us whole again continues to decline, or so it appears.
A fast-track approval process employed by the US Food and Drug Administration (FDA) to bring new products to market more quickly without the traditional, years-long clinical trial process isn’t helping.
There is little doubt that for the majority of Americans, prosthetic knee devices work well and are on track to achieve the assumed service life expectancy of 15 years or more. However, when patients begin having problems with their medical devices - again, in the minority - even an apparent small number can have sufficient statistical impact to warrant a product recall.
That’s what happened last year with the Zimmer Persona Trabecular Metal Tibial plate. The latter is a plate that sits atop the tibia and serves as the surface area for the prosthetic knee device. According to various attorneys engaged in Zimmer lawsuits, a growing minority of patients reported loosening of the plates. This, in part, appears to be exacerbated by a lack of bone growth into the tibial plate, which would serve to anchor the plate. For a statistically large number of patients, this bone growth was either insufficient or not happening at all, leading to Zimmer Persona Knee pain and failure of the artificial knee.
Just referencing the failure of a medical device, implanted into a human body and failing soon after implantation, is serious enough without consideration of where a patient might be, or the activity involved at the point at which an artificial knee fails: driving a car; crossing a busy intersection; skiing; even walking across the kitchen with a steaming hot cup of tea from which a patient could suffer scalds or serious burns were a Zimmer knee to suddenly fail.
Thus, the Zimmer Persona Recall of 2015 when the Zimmer Persona Trabecular Metal Tibial plate was voluntarily recalled by the manufacturer - a recall endorsed by the FDA. Many patients experiencing Zimmer Persona Knee pain from a failed Zimmer Persona Trabecular Metal Tibial plate and requiring revision surgery to replace the failed component(s) are filing a Zimmer Persona Metal Plate lawsuit to seek compensation for pain, suffering and even loss of income. Revision procedures are often more complex than the initial procedure, with higher rates of complication. Having to go through a second surgery so soon after the first, followed by additional rounds of physiotherapy and rehabilitation, can eat into an individual’s income and livelihood given the additional time away from work.
The Zimmer Persona Trabecular Metal Tibial plate, it should be noted, was brought to market through an FDA 510(k) Clearance, the regulator’s fast-track program that allows design updates or new devices substantially similar to those already on the market and performing well to be brought to market without having to go through a clinical trial.
Clinical trials are long-term tests on volunteer patients, conducted to establish the safety and efficacy of a medical device before it is released to market and made available to the general population. If there are problems that surface in clinical trials, the device can be revised prior to a full market release.
Zimmer Biomet (Zimmer) is not the only manufacturer recalling medical devices. Other blue-chip medical devices firms are becoming saddled with recalls. Similarly, the FDA 510(k) Clearance is available to most large device manufacturers.
READ MORE ZIMMER PERSONA LEGAL NEWS
Speaking of Zimmer, US Official News (4/14/16) reports another Zimmer Persona Recall, but this one has to do with packaging. According to the FDA, the recall involved the Persona Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty (REF # 42-5114-008-18).
The recall stemmed from a complaint that there were two sets of information on the box containing the product: One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
The products at issue were distributed to various states in the United States as well as globally (but not Canada).
The Zimmer Persona Recall was voluntary, issued by the manufacturer.