The NexGen CR-Flex Porous Femoral knee replacement system, manufactured by Zimmer Holdings, Inc., has been found by many surgeons to have unacceptably high failure rates. Many patients are suffering pain and difficulty walking, and are facing expensive revision surgery and the ensuing painful rehab.
I am currently reviewing cases and investigating potential lawsuits to help patients receive just compensation for their ordeal and its costs.
According to a study conducted by two surgeons, one of whom was a highly skilled expert on this very device and trained hundreds of surgeons on how to use the Zimmer products, 9.3 percent of patients in the study had revision surgery or were going to have it.
In a filing with the Securities and Exchange Commission, Zimmer states that more than 150,000 Zimmer NexGen knee implants have been sold since 2003.
The NexGen CR-Flex Porous Femoral components have been associated with increasingly high incidences of:
• Knee replacement failure
• Revision knee surgery
• Painful loosening of replacement knee
This knee replacement system is designed to connect the tibia with the knee. The device is fused to the bone on the cap of the thighbone through the use of cobalt-chromium-molybdenum alloy and porous fiber metal that mimics human bone.
Most surgeons implant an artificial knee using a cement-like adhesive to bond the thigh bone to the portion of the device that bends. But sometimes the cement can break down and make the device fail. So Zimmer also sells the “cementless” version of the CR-Flex that relies instead on the bone naturally fusing with the implant.
According to a two-year study ("The High Failure Rate of a High-Flex Total Knee Arthroplasty Design") conducted by Dr. Richard Berger and Dr. Craig Della Valle of the Rush University Medical Center in Chicago, 120 patients were implanted with the device during a period between July and October 2005. Out of the 120 hybrid knees, 108 (90%) knees were clinically evaluated for osseointegration (when the bone naturally fuses with the implant, without intervening soft tissue). Of the 108 cases 39 (36%) are loose. Moreover, many of these 108 cases (9.3%) have had revision or impending revision for painful loosening.
Berger was the expert surgeon who trained hundreds of doctors how to use the Zimmer products. He said in a New York Times article that the knee replacement is designed to last for up to 15 years, but some X-rays showed where the implant met the thighbone, an indication that the device was loose and had not fused completely in less than two years. The exact reason for the device’s failure is unclear; while Berger’s study states other “cementless” brands demonstrate excellent osseointegration and low revision rates. This leads most critics of the device to point to design flaws as a possible reason for the high failure rate.
If you are experiencing problems with one of these knees devices, it is vital that you understand your legal rights and how to protect them.