Zimmer NexGen Recall Issued for LPS Femoral Knee Replacement Parts

About 350 components used as part of Zimmer NexGen knee replacements were quietly recalled last year because some were found to have nonconforming and inconsistent geometry. 

The Zimmer NexGen Complete Knee Solution LPS component recall was conducted in September 15, 2010, with a letter sent to distributors, sales staff, risk managers and surgeons. However, the FDA did not post the recall in its database until December, and neither the manufacturer nor the FDA appears to have issued a press release announcing the Zimmer NexGen knee recall.

The action came shortly after the medical device manufacturer issued a Zimmer NexGen MIS knee recall, which also went widely unreported. That recall, which affected more than 68,000 implant parts, was issued after an alarming number of reports involving Zimmer NexGen knee problems were associated with the components.

As part of the Zimmer NexGen LPS component recall, 158 flex gender femoral components and 192 femoral components of various sizes are affected. The components were sold in the U.S. Germany, Spain, France, the UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania and Austria. It is unclear how many were implanted in U.S. patients.

While the FDA recall notice indicates that surgeons were told of the recall, it indicates that there was no action to be taken by surgeons as part of the action.

Over the past year, a growing number of patients throughout the United States have filed a Zimmer NexGen knee replacement lawsuit alleging that they experienced problems as a result of design defects associated with various components.

Concerns were first raised in March 2010, when Dr. Richard A. Berger, a former consultant for Zimmer, presented data that suggested problems with the Zimmer NexGen CR-Flex knee, which does not appear to have been involved in any recall, resulted in revision surgery in nearly 9% of cases examined and caused knee replacement loosening in more than a third of cases.

Although Zimmer previously paid Dr. Berger millions of dollars to work as a consultant, they reportedly dismissed the surgeon’s concerns and suggested the problems were caused by his surgical skills or technique, not the design of the device.

In August 2010, Senator Charles E. Grassley wrote a letter to the Zimmer CEO and President requesting additional information on what the company was doing to respond to complaints about failures with some Zimmer products and whether there were more consultants who had raised concerns about the company’s implants.