FDA Recall: Zimmer Persona Knee-Trabecular Metal Tibial Plates

On March 12, 2015 the Food & Drug Administration announced a Class 2 Recall of about 11,658 Zimmer Persona knee implant Tibial components parts because of premature loosening and radiolucent lines. These component parts are part of the Zimmer Persona Trabecular knee system. Distributed from 2012 through January 2015 due to the recall, the Persona knee was marketed as “The Personalized Knee System” by Zimmer Inc. Since its launch, the Persona has been linked to numerous failures and complications from patients all over the United States. This Class 2 Recall by the FDA relates to the following system components:

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.

According to the FDA: “An increase in complaints of loosening and radiolucent lines” was noted in the Persona knee system and has been investigated for device failures. As we have seen with many other devices, implant loosening can cause unbearable pain, discomfort and even lead to revision/repair surgeries.

To date, we have received a number of inquiries from patients with the now recalled Zimmer Persona knee implant components and some have already had to have revision due to device failures. Investigations into this knee implant device are ongoing.

As further noted by the FDA:

Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately.

If you received the Zimmer Persona knee implant and have experienced complications with it, please call Childers, Schlueter & Smith, LLC to discuss your legal rights. Our Persona knee implant lawyers are standing by to answer all of your questions. All inquiries are kept completely confidential and all initial consults are free of charge.