According to the U.S. Food and Drug Administration, Zimmer has issued a class 2 recall of over 11,000 units from its Persona line of knee implants. Zimmer has attributed the recall to complaints of loosening of the implant and the appearance of radiolucent lines—gaps between the components of the device or between the device and the bone that can result in severe pain, inflammation, and bone damage. Either of these defects may require patients to receive revision surgery, which can be both painful and expensive.
Zimmer, a medical device manufacturer based in Warsaw, IN, is no stranger to failed products and device recalls. In 2008, the company briefly suspended sale of its Durom Cup hip implant component. It reintroduced the Durom Cup in August of the same year with updated instructions for use. According to a New York Times article, Zimmer stated that only a small percentage of the roughly 12,000 patients who had received a Durom Cup implant would need revision surgery. However, a 2011 study published in Hip International discovered rates for revision surgery to be as high as 15 percent, meaning nearly 2,000 patients who had received a Durom Cup implant would have to pay for and suffer through revision surgery.
Furthermore, in June of last year, Zimmer recalled more than 40,000 of its NexGen MIS Tibial knee implant components. According to a letter sent out to risk managers and surgeons, the components were recalled because of concerns that “the threads may be out of specification”. This defect could potentially lead to greater risk of infection, additional bone loss, and loosening or dislocation of the implant, which could require early revision surgery.
The attorneys at Lopez McHugh are dedicated to protecting the health and rights of consumers who have been injured by recalled products. If you or someone you know suffered from a failed Zimmer knee or hip implant, contact our lawyers today for a free consultation. You may qualify for compensation through a Zimmer knee or hip lawsuit.