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Peter J. Brodhead | Dec 12, 2014

Was Zimmer Aware of the Issues Associated with the Recalled Persona Hip Implant?

Categories: Defective Drugs and Medical Devices

Zimmer was established in Indiana, in 1927, by Justin O. Zimmer. During its very first year, the company realized sales of $160,000 from aluminum splints and other orthopedic equipment. Prior to a merger with Biomet in June 2015, Zimmer employed almost 8,500 people and sold to 100 countries. Following the Biomet merger, Zimmer Biomet is now considered the top innovator in the $45 billion musculoskeletal healthcare market, controlling approximately 26 percent of knee replacement sales. Unfortunately, there have been problems with several of Zimmer’s knee replacement models. In March 2015, Zimmer issued a recall for the Persona Trabecular Metal Tibial Plate. The Tibial Plate is designed to affix to the recipient’s knee bone without the use of cement. Zimmer claims the design closely resembles that of a person’s own knee.

COMPLAINTS RECEIVED REGARDING THE ZIMMER PERSONA TRABECULAR METAL TIBIAL PLATES

Zimmer began receiving complaints regarding components releasing, as well as gaps between the tibial plate and the bone or between the different parts of the Persona, known as radiolucent lines. Radiolucent lines generally occur when a component of the device is not correctly secured, allowing the gap to fill with tissue, joint fluid or implant wear debris. The destruction or disappearance of bone tissue—known as osteolysis—can follow, leading to implant loosening. More than 11,658 Zimmer Persona Trabecular Metal Tibial Plates were recalled voluntarily by Zimmer, soon after an Urgent Medical Device Recall was issued by the company in February, 2015.

This notice stated that all Persona Trabecular Metal Tibial Plates were to be immediately identified and quarantined, although those devices already implanted could not, obviously, be quarantined. Persona Trabecular Metal Tibial Plates are used in minimally invasive knee replacement surgeries in which a 4-5 inch incision is used, rather than the more traditional 8-12 inch incision. The minimally invasive procedure allows a reduction in blood loss as well as a shorter recovery time for the patient, however the actual surgical technique used is much more challenging with a greater margin of error.

DECREASED MOBILITY RESULTING FROM ZIMMER PERSONA KNEE IMPLANT

At the time of the Zimmer Persona Trabecular Metal Tibial Plate recall, approximately 40 complaints across the globe had been received regarding loosening of the Persona implant. Of those 40 complaints, 16 patients had been forced to undergo revision surgery. Other Persona implant recipients have experienced increasing levels of knee pain, difficulty walking and decreased mobility. When Zimmer released the Persona knee implant in March 2012, the company claimed it was redefining knee arthroplasty, ushering in a “new era of personalization…” Yet after less than three years on the market, Zimmer issued a recall of the Persona tibial plate.

WAS FINANCIAL GAIN RESPONSIBLE FOR THE DELAY IN THE PERSONA RECALL?

There are multiple factors which influence whether a device will be recalled, including public outcry over injuries related to the device as well as whether the FDA steps in. Unfortunately, many recall decisions hinge strongly on financial gain. If a certain product is very profitable and the manufacturer believes doubt can be cast regarding the supposed link between the device and injuries, there may be little incentive to consider consumer safety. Most manufacturers of a medical device also resist admitting there is a problem, believing such an admission opens the door to a flurry of lawsuits.

Many wonder whether Zimmer was aware of the potential risks associated with the Persona Trabecular Metal Tibial Plate. As time passes and more injured Persona patients come forward, it may be found that Zimmer failed to warn patients of potential Persona risks, failed to properly test the Persona, released inaccurate statements regarding the Persona’s safety and effectiveness and engaged in improper marketing of the Persona. If you have sustained injuries from a Zimmer Persona Trabecular Metal Tibial Plate, you may be eligible to receive compensation for your medical expenses, pain and suffering and lost income.