Problems with the Zimmer NexGen Knee Replacement System have reached an unacceptably high level, according to two prominent university orthopedic surgeons.
The researchers presented their information at a March 2010 meeting of the American Academy of Orthopedic Surgeons. They reported that 9 percent of patients examined after two years of knee replacement surgery needed another surgery, called revision surgery, to correct unacceptable flaws in the implants. Thirty-six percent of patients’ artificial knees were loosening.
The artificial knee failures are thought to be due to design defects in the implants. Zimmer, the manufacturing company responds that the surgeons are not implanting the prostheses correctly.
The problem seems to be with the “high-flex” porous femoral (thigh bone) component attached to the bottom of the bone. Most knee replacement devices are fastened in place by a kind of surgical cement. NexGen CR Flex, however, doesn’t use the cement and instead uses a non-cement attachment method.
Zimmer NexGen Knee Replacement System Problems
The problems with the knee implants include:
- Failure of the implant
- Need for revision surgery
- Loosening of the prosthetic knee
- Knee pain and other complications
The researchers reporting the problems at the meeting were from Rush University Medical Center. They found that nine of 108 patients needed knee revision surgery because they were in pain and their implants were loosening.
In addition, their studies revealed that 39 of the 108 patients’ x-rays showed the implants were loosening. These findings, despite Zimmer’s assertions, did not correlate with any specific surgeon, surgical approach, or type of patients, the researchers said.
“Horrific” is how the head researcher of the study described the failure rate.
Australia keeps a National Joint Replacement Registry. Since 2004, it was recorded in the registry that 120 patients who had Zimmer NexGen knee implants required knee revision surgery.
More than 150,000 Zimmer NexGen knee implants have been sold since 2003. While orthopedic surgeons are asking for a recall, the company said it continues to believe in the efficacy and safety of its product.
Senator Charles Grassley (R-Iowa) sent a letter in July 2010 to Zimmer Holdings. Senator Grassley said in the letter that the Senate Finance Committee was investigating the safety of the Zimmer NexGen knee replacement system.
Contact a Defective Medical Devices Attorney
If you or someone you love has experienced problems with a Zimmer NexGen Knee Replacement System, contact the defective medical device attorneys of Gacovino, Lake & Associates for qualified legal representation. We will evaluate the specifics of your case to determine if your claim has merit. If so, we will fight aggressively on your behalf. Call 1-800-246-4878 to schedule an evaluation of your case.
