Zimmer Knee Replacement Lawsuit - NexGen Complications

Zimmer NexGen MDL Gains New Case

Neal Donaghy | September 11th, 2013

Zimmer knee replacement lawsuitAnother Zimmer knee replacement lawsuit has been added to the ongoing multidistrict litigation proceedings (MDL No. 2272) against the orthopedics manufacturer. The complaint was lodged last month in the U.S. District Court for the Southern District of New York, and is described in court documents as ‘a related action’ in the MDL, which is being heard in the Northern District of Illinois.

The plaintiff’s left knee was implanted with the NexGen knee device in December 2008. By October 2010, she had suffered a series of Zimmer knee problems, ultimately requiring revision surgery. Neither the plaintiff nor her doctors were aware of the now highly-publicized failure rate of the implant.

Her Zimmer knee replacement lawsuit is one of more than 700 similar cases currently pending. The complaints, which have come from all over the U.S., allege that Zimmer failed to properly test various knee replacement systems and individual components. Hundreds of people have experienced debilitating complications as a result of purported design flaws in the NexGen implants. The products liability NexGen MDL is proceeding under the auspices of Judge Rebecca R. Pallymer.

High-flex component blamed in Zimmer knee replacement lawsuit

Since first emerging during the mid-90s, the NexGen line of knee replacements has been implanted in some three million patients. Increasingly, recipients are complaining of pain and early failure of the device, often occurring within months of surgery. This puts Zimmer’s system’s life expectancy well below the expected lifespan of more traditional knee implants, which typically last for around a decade.

When they were first released, Zimmer claimed the NexGen system was the future of knee implants. It uses a high-flex femoral component which provides a greater degree of flexibility than the components found in traditional knee implants. The LPS Flex component accommodates 155 degree flexibility, compared to the 125 degree flexibility found in older devices.

The LPS Flex undoubtedly gives better contact between the femur and the tibia during knee bending, but the increased flexibility promotes much more wear and tear in the joint, meaning more tissue damage and a shorter implant lifespan. Hundreds of patients have complained of loosening of the femoral components. A growing body of research appears to corroborate their claims.

A 2007 study published in the Journal of Bone and Joint Surgery showed that 38% of LPS Flex implants had loosened within two years of surgery. Around 50% of those patients were forced to undergo revision surgery. A non-peer reviewed report compiled in 2010 by orthopedic surgeon Dr. Richard Berger expressed the physician’s personal concern regarding the high failure rate of the CR-Flex. Berger’s review looked at 108 recipients of the implant and found that 36% of recipients had experienced loosening of the component. Revision surgery was required by 8.3% of them within two years of implantation.

Zimmer stands by its products

Zimmer has consistently stood by the NexGen systems, although in 2010 they withdrew some implants that contained the defective component. In the same year, they issued ‘urgent device correction and removal’ notices to distributors and surgeons. Publicly, Zimmer still describes the NexGen Knee Replacement System as ‘clinically proven and the most trusted knee replacement system in the world.’

FDA, Class 2 Recall NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=92118&CREATE_DT=2010-09-13