In March 2015, the Food and Drug Administration (FDA) announced that a voluntary recall had been made by Zimmer Biomet pertaining to the Zimmer Persona Trabecular Metal Tibial Plate knee implant component.  The recalled Zimmer knee implant had received several patient complaints prior to the recall.

This announcement was made following patient reports alleging adverse side effects caused by the Zimmer Persona knee implant coming loose from where the product was initially implanted. Reports suggested that some of the patients with Zimmer Persona knee implants experienced gaps between the bone and the inserted knee implant. Professionals suggest this gap is a sign of “poor seating” resulting from the implant.

Signs of adverse effects or complications of a failing Zimmer Persona knee implant can include, but are not limited to the following: loss of mobility, inflammation, persistent pain, knee instability, and knee tightness.

Recalled Zimmer Knee Implant Component: Additional Facts

The recalled Zimmer knee implant component is the Zimmer Persona Trabecular Metal tibial plate. It is a metal component of a total knee replacement and is attached to the bone without cement.  The Zimmer Persona becomes attaches to the tibia by two pegs that become implanted into the bone. These pegs then connect directly with the bone after the product’s implantation. The two pegs are meant to give additional stability to the Zimmer Person knee implant.

The Zimmer Persona TM implant voluntary recall was announced in 2015 by Zimmer.  The recalled Zimmer knee implant affected approximately 12,000 Trabecular Metal plate units. The recall was announced after the company received complaints of adverse effects and complications resulting from the product’s implantation.

Another complication linked to the recalled Zimmer knee implant appears as radiolucent lines. Radiolucent lines are X-ray evidence of gaps appearing between the bone and the knee implant. This is also a sign of “poor seating,” which occurs when the implant, which is supposed to be firmly placed in position, moves around from its intended placement. These radiolucent lines that appear are the signs of loosening of the recalled Zimmer knee implant occurring.

Zimmer affirms that loosening of the implant “is one of the most prevalent causes for revision in total knee arthroplasty.”  Following Zimmer’s voluntary recall, the U.S. Food and Drug Administration announced it in March 2015.

The FDA announced the level of this recall as a “Class 2 Recall,” the term pertaining to products, devices, or drugs that cause temporary or reversible harm. The FDA announced that the recall applied to all sizes of the Zimmer Persona Trabecular Metal tibial plates and that variations were affected.

Complaints pertaining to the recalled Zimmer knee implant stated that roughly 38% of patients who had been implanted with the device complained of radiolucent lines and many have had to undergo revision surgery due to the failure of the device.  Knee revision surgery increases a patient’s risk for further complications related to the procedure.

Some of the reasons and symptoms leading to revision surgery include the loosening of the device, lack of ingrowth, loss of fixation, instability, fracture, patella tracking issues, component failure, persistent pain, and a globally tight knee.