Is Another Zimmer Knee Recall On the Way?
Patients who experienced complications after knee replacement, often requiring knee revision surgery, due to Zimmer knee failure of the CR-Flex model, are confused as to why neither the artificial knee maker nor the FDA has issued an unrestricted Zimmer knee recall. How will a lawsuit be affected by the limited Zimmer knee recall that was issued? And does a more comprehensive Zimmer knee recall loom on the horizon?
Zimmer Knee recall history
The Zimmer NexGen CR Flex knee was designed to last for 15 years in patients with active lifestyles. In 2010, however, a report by the American Academy of Orthopaedic Surgeons (AAOS) claimed that premature Zimmer knee failure occurred at an unexpectedly high rate of 36% in the 108 cases investigated. Almost one-third of the device malfunctions required removal and knee revision surgery. In many cases Zimmer knee failure occurred in the CR-Flex model reported on after only two years following implantation.
Lead researcher called for Zimmer Knee recall
The lead researcher of the AAOS study was Dr. Richard Berger, a noted orthopedic surgeon who had previously worked for years as a highly paid consultant to Zimmer. Despite having initially championed the NexGen CR Flex knee replacement device, he ultimately advocated a Zimmer knee recall; the report concluded that the cementless, high flex femoral component has a high incidence of failure… it is still commercially available but should not be used for any patient.
A voluntary Zimmer knee recall of the NexGen MIS Tibial components followed in 2010, but did not target the NexGen CR Flex replacement device as a whole, but only certain constituent parts, specifically the NexGen MIS Tibial components. These component parts were recalled due to a “noncomforming geometry” that kept them from properly interlocking with each other. This tendency to dislocate resulted in Zimmer knee complications such as pain, infection, immobility, and osteoarthritis.
Zimmer Knee failure issues regarding CR-Flex model partially addressed by revised surgical instructions
Zimmer currently issues a new set of more in-depth and precise surgical instructions with the NexGen CR Flex knee. Despite increased numbers of plaintiffs filing a Zimmer knee lawsuit, the prosthetic manufacturer continues to insist that instances of dislocation and malfunction are not caused by problems with the implant, but are instead due to error on the part of the surgeon who performed the procedure.
Joint registry to track all replacement failures including Zimmer Knee failures
Recently, two data-tracking organizations, including the American Joint Replacement Registry (AJRR), have started to gather information on the success and failure rates of all artificial hips and knees issued in the U.S. If this data eventually shows that the rate of Zimmer knee failure with respect to the NexGen CR-Flex model is as high as previous studies and anecdotal evidence have shown, then a full Zimmer knee recall could be the result.
One of the expected outcomes of such a recall would be a push towards pre-trial Zimmer knee settlements with a Zimmer Knee lawyer in pending lawsuits.