Patients Complain About Zimmer NexGen Problems

Newark, NJThe number of lawsuits concerning the Zimmer NexGen knee replacement continues to grow, a sign that more patients are suffering failure of their knee implants. Some Zimmer components have been recalled, although the Zimmer NexGen CR-Flex itself has not.

According to The Wall Street Journal (2/6/12), a study conducted at the Mayo Clinic found a problem with the Zimmer NexGen knee that contained a certain tibial component. The problem is called isolated debonding, and it occurs when the implant detaches from the cement that holds it in place. Implants coming loose from the bone made approximately fifty percent of device failures. Of those device failures linked to implants coming loose, 80 percent were caused by isolated debonding.

Researchers said isolated debonding was not seen in other implants used at the Mayo Clinic.

Lawsuits have been filed alleging patients suffered pain and loosening of the implant requiring revision surgery. As a result of the revision surgery, they say they suffered economic damages due to time off work to recover from the surgery. There are reportedly around 500 lawsuits consolidated in Zimmer knee multidistrict litigation.

Included in the lawsuits are Zimmer knee devices that include the LPS-Flex components, CR-Flex components or LPS-Flex components. Some MIS Tibial components have been recalled, but others remain on the market. It is important to note that there has not been a recall issued for the entire Zimmer NexGen CR-Flex knee replacement line. Only components included in the line have been subject to a recall.

The Zimmer NexGen CR-Flex was designed to give patients more mobility than the original NexGen. The CR-Flex reportedly comes in both a cemented and uncemented version, for specialists who feel the cement can break down, causing the implant to fail. In devices without cement, the implant is meant to fuse with the bone to hold it in place.

The New York Times (6/19/10), reports that the Zimmer NexGen CR-Flex was meant to last 15 years, but some patients experienced pain a year after having the device implanted. The problem was the device had not fused to the bone. Dr. Richard A. Berger and Dr. Craig J. Della Valle, both of who implanted Zimmer knees, presented a study in 2010 at a national meeting of the American Association of Orthopedic Surgeons. They found that the Zimmer knee without the cement had an early failure rate of around nine percent, but up to 50 percent of patients showed signs of the device loosening.