Zimmer Persona TM Tibia Plate Recall
On March 12, 2015 the FDA initiated a Class 2 recall of the Trabecular Metal tibial component of Zimmer, Inc.’s Persona Knee. The component is being recalled because it can loosen after implantation. This loosening can lead to pain, swelling, clicking, limitation on range of motion and device failure. The orthopedic medical device company initially warned its customers in February of, “an increase in complaints of radiolucent lines and loosening.”
The March recall states: “Zimmer, Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial [Plate] following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution.
All affected products are to be located and quarantined immediately
The presence of radiolucency is usually found on x-ray, where dark lines or gaps can be seen in between the implant and the host bone. The tibial plate plays a significant role in the knee replacement, and loosening of this component can lead to premature and sometimes catastrophic failure of the implant.
If you or a loved one was implanted with the Zimmer Persona Knee and would like a free consultation to discuss your claim, please contact our office. Keefe Law Firm has recovered millions of dollars on behalf of patients who suffer from a defective medical device. Your claim is time sensitive, so please contact us at your earliest convenience.