Zimmer Initiates Class 2 Recall of Persona Trabecular Metal Tibial Plate

The Food and Drug Administration issued a press release from Zimmer, Inc., on March 12, 2015 “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.” The company asks that any healthcare providers who purchased the product be aware of the potential hazards, and that all products be returned to Zimmer, Inc. along with an Inventory Return Certification Form.

According to the FDA, a Class II recall is issued when using a product, or being exposed to a product, “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Thus, the tibial plates being recalled by Zimmer may not be as dangerous as other product recalls, making this voluntary recall more preventative than anything else.

Tibial plates are used in total knee replacement surgeries, where a surgeon must fix or replace all three parts of a knee joint. The plate is made of metal and designed to bear weight.

Zimmer’s history of recalls

Zimmer Initiates Class 2 Recall of Persona Trabecular Metal Tibial PlateZimmer has recalled a number of its knee and hip replacement components over the years, including:

  • NexGen Lateral Posterior Stabilization (LPS)-Flex knee replacements
  • NexGen Cruciate Retaining (CR)-Flex knee replacements
  • NexGen Minimally Invasive Solutions (MIS) Tibial Component
  • Durom Acetabular Component, or Durom Cup, hip replacement

In fact, Zimmer is currently facing off in court attempting to have certain lawsuits against them for the Durom Cup time-barred, though there is still no word whether or not they will be successful in their motion to have the suits dismissed.

The NexGen products were supposed to emulate a real, natural knee joint, giving users greater flexibility. Instead, the parts often failed prematurely, leading to costly, painful and time-consuming revision surgeries – many of which were not covered by patients’ insurance plans.

If you have had a total knee replacement and are suffering with the effects of a defective Zimmer tibial plate, we may be able to help. Please contact our firm to schedule an appointment in our Maryland office.