Zimmer Persona Trabecular Metal Tibial Plate

By Heidi Turner

In 2015, Zimmer, maker of the Persona Personalized Knee System, announced it was voluntarily recalling a component in the knee replacement device, the Persona Trabecular Metal Tibial Plate. The Trabecular Metal Tibial Plate recall was announced in February 2015 and was classified by the FDA as a Class II recall in March 2015.

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Zimmer Persona Trabecular Metal Tibial Plate Recall

On March 12, 2015, the US Food and Drug Administration (FDA) announced a voluntary Class II recall of the Zimmer Persona Trabecular Metal Tibial Plate. At the time, the FDA noted that all sizes and lots of the affected devices were being removed from distribution "following an increase in complaints of radiolucent lines and loosening."

An FDA Class II recall occurs when a product may cause temporary or medically reversible adverse health consequences to the patient.

Patients who have had the Trabecular Metal Tibial Plate implanted have reportedly suffered serious complications, including loosening of the tibial component, resulting gaps between the plate and the patient's bone. Patients who experience loosening of the component may require additional surgery to remove and replace the tibial component.

Approximately 11,700 units are affected by the recall.

Zimmer Persona Knee

The Zimmer Persona Knee is marketed as a personalized knee system. Among the benefits of the Persona Knee touted on Zimmer's website are comprehensive sizing, integrated intelligent instruments and side-specific kinematics. The Trabecular Metal Tibial Plate is a component in the Persona Knee System. It is designed for use without cement.

Signs of potential problems with the Trabecular Metal Tibial Plate include pain, lack of mobility, instability in the knee, and inflammation. Patients who have the knee implanted and are experiencing unusual pain or instability should speak with their doctor to discuss their options.

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Last updated on Aug-4-15

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