March 24, 2015 — Zimmer Inc. has issued a Class II recall for a metal knee replacement that may be prone to loosening.
The recall affects about 11,658 of the Persona Trabecular Metal Tibial Plate, including all sizes and lot numbers. Zimmer warned surgeons about the problem in February after receiving “an increase in complaints of loosening and radiolucent lines.”
The products were sold throughout the United States between November 2012 and early 2015. Zimmer has received about 6 complaints of loosening or radiolucent lines (a risk-factor for premature failure) for every 1,000 devices implanted, which is higher than expected when compared to similar devices.
However, the actual number of injuries may be even higher, especially for devices that remain implanted in a patient for a longer period of time. About 36% of the complaints involved revision surgeries for loosening and/or symptomatic radiolucent lines.
According to Zimmer:
“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.”
The Persona was a “personalized knee” implant that was designed to provide greater accuracy in its fit, tailored to each patient’s unique anatomy. Instead, patients may experience problems with initial fixation, which can cause knee pain, loosening, and long-term health problems. Some patients may require revision surgery to remove and replace the implant.
Zimmer distributed the implants in the United States, Europe, Australia, and other parts of the world. They were also sold to at least 13 Veterans Affairs (VA) hospitals in the United States.
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