The device was introduced just three years ago, and hailed by Zimmer at the time as having “anatomically accurate components available for a new level of fit tailored to each patient’s unique anatomy.”
However, it appears that reality didn’t correlate with the hype, as numerous reports of failures prompted Zimmer, this past February, to issue a voluntary recall of the Persona Trabecular Metal Tibial Plate system. All lots and sizes C-J, both left and right, have been recalled, representing some 11,658 units manufactured and marketed between 2012 and this year. The US Food and Drug Administration (FDA) supported Zimmer’s Urgent Medical Device Recall notice with the issuance of a Class 2 recall on March 12. The recall encompasses lots and sizes of the Persona Trabecular Metal Tibial Plate used during knee replacement procedures between November 2012 and early 2015.
In its directive to hospitals, Zimmer said that “out of the complaints received, 36 percent identified symptomatic radiolucent lines or were revised for loosening, 28 percent identified asymptomatic radiolucencies, 8 percent subsided, and 28 percent were inconclusive. Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.”
Zimmer noted that six out of every 1,000 implants had the potential to fail, although expert medical opinion is of the view that such a failure rate could easily increase over time.
The Zimmer Persona Recall is the latest in a slew of product recalls involving new-age medical devices thought to improve upon tried-and-true designs of yesteryear, only to prove not only disappointing in real-world practice, but also resulting in complication and inconvenience for the patient. Initial knee replacements require time to heal and recover following the procedure. A failed implant can not only leave a patient hamstrung and in severe Zimmer Persona Knee pain, but can also require revision surgery that is usually more complicated than the initial procedure, requiring even longer healing times and absences from work.
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Manufacturers have the freedom to skip advanced clinical trials if a proposed medical device is substantively similar in design to existing devices on the market through the employment of a 510(k) Clearance from the FDA. It is not known if the Zimmer Persona knee system was brought to market through the employment of the 510(k) shortcut.
Given the rising number of knee replacement procedures amidst an aging population, it is expected that thousands of patients could be affected - with many filing a Zimmer Persona lawsuit to pursue a compensation claim.