Defective medical devices update: In March 2015, the United States Food and Drug Administration issued a recall for nearly 12,000 Zimmer Persona Trabecular Metal Tibial Plate knee implants. One month earlier, Zimmer sent an Urgent Medical Device Recall notification to hospitals and surgeons, instructing “all affected product” to be located and quarantined immediately.
Zimmer is an Indiana based manufacturer of medical devices. It is the world’s largest maker of knee replacement implants, commanding 26 percent of the knee replacement market. Worldwide, Zimmer’s knee replacements earn an estimated $7.2 billion.
The company’s Persona Knee system was promoted as being much like a natural knee with the flexibility to be used ith a wide variety of components and in numerous surgical styles. The Personal Knee system was designed to be used without cement. However, Zimmer reported that it has received an increasing number of complaints that the knee implant was not secured correctly. Gaps between the knee implant and bone or gaps between the implant components can become filled with joint fluid, tissur or “debris” from wear. The result can be osteolysis bone damage leading to loosening and failure of the implant.
The Persona Knee is not the first Zimmer knee implant to be recalled. In 2010, the NexGen MIS Tibial component used with Zimmer NexGen Flex knee implants was recalled by the FDA, and in January 2012, the Natural Knee II Durasul All-Poly Patella was recalled due to reports of fractures causing the device to fail.
If you or a family member has been injured by a defective Zimmer knee implant – or other defective medical devices, the medical device attorneys at Clark, Perdue & List may be able to help.