Zimmer Persona Knee Replacement Device Lawyers

Back in March 2015, the Food and Drug Administration (FDA) announced that Zimmer Biomet—a manufacturer of medical devices—would be recalling parts from its Persona knee replacement devices. The FDA’s announcement followed claims by tens of thousands of patients that the Zimmer Persona Knee Replacement Device models caused adverse symptoms and complications.

The FDA explained in an announcement concerning the recall that one of the components in the knee-replacement device was prone to become loose with far greater frequency rate than had been anticipated based on studies. The Persona Trabecular Metal Tibial Plate, which is fitted between two bones that make up the knee joint, proved problematic when patients used the knee after a replacement procedure.

Thousands of patients who received the Zimmer Persona knee implant reported injuries and medical complications caused by the implant. According to the patients, the Zimmer Persona knee implant failed to work properly, resulting in knee implants loosening prematurely. They alleged that the tibial plate of the knee replacement device failed to work properly and became loose, causing injuries in many cases.

A loosening of the tibial plate can prove extremely dangerous, according to medical experts. Loose tibial plates in the knee can cause swelling, pain, excessive fluid buildup around the joint, and potential permanent tissue damage. Furthermore, patients who received the defective medical devices frequently have to undergo a revision surgery. In the context of knee replacements, surgeons have been required to undertake a second replacement procedure, increasing risks to paitents.

Zimmer has recalled several different knee implant products. The company initiated its own recalls of knee implant devices in 2008, 2010, and 2014. Every time the company announced a recall of its knee implants, it pointed out that the affected devices had failed at much higher rates than anticipated.

Patients who received the recalled items in procedures suffered injuries caused by knee implant device failures, resulting in severe pain and additional injuries, including:

• Loosening of the device, or device failure, which required knee replacement revision surgery;
• The components of the device developing large gaps resulting in fluid buildup, resulting in immobility and pain;
• Debris from parts rubbing together flaking off and becoming lodged in the knee joint, causing muscle tissue and bone damage.

When it debuted the knee replacement system, the Zimmer company promised that the implant would reduce pain and increase recipients’ mobility. The rosy projections about the implant caused many medical practitioners to recommend surgery over less-invasive traditional medical techniques such as physical therapy.

Zimmer advertised its Persona system to surgeons as a cutting-edge product that would change the lives—for the better—of many patients. The Persona system, the company claimed, enabled patients to consider a knee replacement procedure without the significant risks that such an invasive procedure would usually include. Patients who received the implants, however, complained that Zimmer engaged in false advertising and failed to warn surgeons and patients alike of the significant medical risks that the system posed to recipients.

Over the years, Zimmer has established itself as one of the top producers of medical devices—and specifically knee-implant devices—in the world. The Persona system has not been the only knee-implant system to become subject to recall, and Zimmer has faced thousands of claims from patients across the United States who have contended that the failure of their Zimmer knee replacement systems led to significant injuries and complications. Some industry observers, along with claimants in cases, have wondered if the company rushed its products to market too soon, before the significant complications that became associated with them surfaced.

Under North Carolina law, medical device manufacturers have a legal duty to ensure that their products are reasonably safe. Claimants in actions against Zimmer stemming from injuries they allege were caused by the Persona knee implant system contend that Zimmer did not consider the potential defective design flaws in the product. The failure to consider the defective design, claimants have alleged, led to significant injuries and complications.

If you or a loved one has suffered injury caused by a Zimmer Persona knee replacement device, you may be entitled to compensation. The best thing you can do if you suspect that a faulty device caused injury to you or a loved one is contact Arnold & Smith, PLLC to schedule a free initial consultation.