Total knee replacement systems are designed to last between 15 and 20 years, but some of the prosthetic knees currently on the market are failing within just a few years of the initial replacement surgery. According to Zimmer Inc., one of the largest manufacturers of knee and hip replacements, the company’s Persona knee device was “designed to minimize the compromises experienced with yesterday’s standard knee systems.” However, Zimmer recalled its Persona knee components within three years of the FDA’s initial approval, based on concerns that the devices could loosen prematurely and cause serious complications. If you have suffered injuries allegedly caused by a Zimmer Persona knee implant or Trabecular Metal Tibial Plate, contact a knowledgeable defective knee implant lawyer today for legal help.
Despite claims by Zimmer that its Persona knee replacement system provided the “best fit” for individuals in need of a prosthetic knee that allowed them to return to their normal activities, the knee implant may actually put patients at risk for debilitating complications. According to reports, the main issue plaguing recipients of Zimmer Persona knees is the appearance of radiolucent lines, or gaps between the knee components or between the components and the bone. In some patients, joint fluid, tissue and debris from the implant components may become lodged in those gaps, which can lead to osteolysis, or bone damage, as well as implant failure, swelling and severe pain requiring revision surgery. Revision surgery is typically more complicated than the original knee replacement surgery and can result in a longer recovery time for patients. As a result of early implant loosening and other problems allegedly affecting the Zimmer Persona knee replacement system, product liability lawyers across the country are investigating claims on behalf of patients who received a Zimmer Persona Knee or a recalled Trabecular Metal Tibial Plate, and have since suffered aseptic loosening or other complications.
Zimmer’s Persona Personalized Knee System was marketed as a knee replacement system for younger, more active people who required a longer-lasting device that offered a better range of motion than older knee replacements. The prosthetic knee implant allowed surgeons to personalize the device to the individual needs of the patient in order to mimic better than any other device on the market, the natural movement of the human knee. The Zimmer Persona Knee was approved by the FDA in 2012, via the agency’s “fast-track” approval process, which allows manufacturers of knee implants and other medical devices to bring their products to market without subjecting them to rigorous clinical trials, so long as a similar product already exists on the market. This legal loophole allows untested and potentially defective devices on the market without any proof that the products are safe or effective for consumer use. Unfortunately, this sometimes results in new medical devices being approved based on the merits of older devices that eventually end up being recalled.
Dozens of joint replacement systems have been recalled in recent years, amid reports that the prosthetic implants are prone to premature failure, sometimes occurring just a few years after the initial replacement surgery. In 2015, the FDA issued a notice of a Class II recall affecting more than 11,600 Zimmer Persona Trabecular Metal Tibial Plate knee components, due to complaints that the prosthetic knees are prone to premature loosening and other serious complications, including the appearance of radiolucent lines. In a 2006 study published in The Journal of Arthroplasty, researchers reported that radiolucent lines are a known cause of early knee implant loosening, which is directly related to an increased risk of premature device failure.
This isn’t the first time Zimmer has faced reports of early implant failure and other problems with its joint replacement systems. In 2008, Zimmer issued a temporary recall of its Durom Cup hip implant, in response to reports of metal toxicity and tissue damage leading to premature implant loosening. In 2010, Zimmer recalled nearly 70,000 MIS Tibial components, as well as femoral components used in the LPS system, and in 2014, the company recalled 40,000 NexGen Knee implants because of defective screws. In 2015, the same year Zimmer recalled its Trabecular Metal Tibial Plate components, the company also recalled its Persona Tibial Articular Surface Provisional (TASP) Shim tool, amid concerns that a breakdown of the ball bearing retention component of the tool, known as the “swage,” after sonic cleaning may result in ball bearings being ejected during surgery and left in the surgical wound.
For patients with Zimmer Persona knees or recalled Trabecular Metal Tibial Plates implanted between November 2012 and February 2015, who have suffered aseptic loosening of the device, a lawsuit can help cover the cost of:
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