On March 12, 2015, the United States Food and Drug Administration (FDA) announced that Zimmer Orthopaedics, the world’s largest producer of knee implants, had issued a Class II recall of the company’s Persona Trabecular Metal Tibial Plate. The Persona Trabecular Metal Tibial Plate is a modular tibial component, meaning it can be paired with different femoral and patellar components depending on a patient’s anatomy and physical needs to comprise a knee implant system.
All sizes and lots of the Persona Trabecular Metal Tibial Plate knee implant are being removed from distribution. A Class II recall is required when a medical device can cause temporary or medically reversible adverse health consequences.
The recall was necessary due to growing complaints of implant loosening and reports of “radiolucent lines” or transparency of the component in x-rays. Radiolucent lines are large gaps in between device components or between the components and the bone. Metallic debris, joint fluid, and hip tissue can wedge into the large gaps leading to osteolysis. Loosened components can also cause severe pain, swelling and tissue and bone damage requiring a revision surgery.
According to the FDA notification, the recall affects 11,658 Persona Trabecular Metal Tibial Plate devices that were sold in twenty-five different U.S. states. The Zimmer Persona Trabecular Metal Tibial Plate knee implant was distributed to Veteran’s Administration (VA) Medical Centers in numerous states, including Alabama, California, Georgia, Indiana, Massachusetts, Missouri, New York, Ohio, Pennsylvania, and South Dakota.
If you or a loved one has been injured by a prescription drug or medical device, you may be entitled to pursue a claim against the manufacturer for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.