No one intends to undergo a knee replacement, but when it becomes a necessity, patients expect that their artificial knee will become a permanent part of their body and work the way the device manufacturer intended. However, the recent Zimmer knee replacement recall, which only affects a component of the device known as the “Persona TM Tibial Plate,” has put questions into the minds of some patients and doctors about the safety of Zimmer’s medical devices.

The Zimmer Persona knee replacement system is a seemingly innovative knee replacement system which can help thousands of patients regain mobility in their knee areas.

The way that the Zimmer Persona knee replacement system is different from other knee implants is in its trabecular metal tibial plate. This is a metal component of the Zimmer Persona system, and it is attached to the tibia without cement. Two pegs are inserted into the bone with the intent that the bone will grow around the trabecular metal tibial plate to give it strength.

On its website, Zimmer claims that the Zimmer Persona knee replacement system has three major benefits: personalized implants, precise instrumentation and proven technology.

Zimmer claims that that they worked with “over 50 of the most respected orthopaedic surgeons worldwide and utilizing analytics from 1,500 different bone types representing 26 ethnicities and both genders,” and that their goal was to “come as close as possible to the remarkable mechanics of the human body where form truly does follow function.”

The problem with the Zimmer Persona knee replacement system is that while a normal joint implant should last a patient upwards of two decades, patients were reporting major problems with their implants well within the first decade after implantation.

Two of the major issues that were reported led to many complications including the need for revision surgery. X-rays revealed radiolucent lines appearing near patients’ implants. Radiolucent lines are gaps between the knee implant and the bone. This is a sign that the implant is not “seated” correctly or that it is in the wrong place. The implant, in this case, may have begun to move from where it was originally placed.

The second major issue that Zimmer Persona knee replacement patients were beginning to experience was loosening. Loosening, in these cases, occurs when the trabecular metal plate is no longer secured to the tibia as it should be.

Zimmer issued a voluntary Zimmer knee replacement recall for nearly 12,000 trabecular metal components in 2015. In reaction, the U.S. Food and Drug Administration took notice of these reports and Zimmer’s own recall and issued a Class II Zimmer knee replacement recall for these devices.

The FDA noted, “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.”

A Class II Recall, like the Zimmer knee replacement recall, is issued when a product can cause temporary or medically reversible adverse consequences.

If you or someone you love has been affected by the Zimmer knee replacement recall, you may be eligible for compensation.