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In March 2015, Zimmer Inc. issued a Class II recall for the Zimmer Persona Trabecular Metal Tibial Plate. The device-maker has received an unusually high number of complaints involving premature loosening of the implant and poor fixation. The company has reported approximately 6 complaints per 1,000 devices implanted, which is higher than the rate of complaints for similar implants.
About 36% of the complaints involved patients who had symptomatic problems, radiolucent lines, and/or needed revision surgery due to premature loosening of the implant. Zimmer warned:
“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.”
The recall includes nearly 11,700 implants in all lots and sizes C-J. They were sold from November 2013 through January 2015 throughout the United States and in other countries.
Radiolucent lines are dark lines that are seen on X-rays. They are a symptom of a poorly-fixated knee implant. They are also associated with premature loosening and failure of the acetabular component of the knee implant.
Zimmer marketed the Persona knee as the “most clinically successful knee replacement more personalized than ever.” Instead, many people who were implanted with this device have experienced serious problems or needed revision surgery.
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