Tuesday, February 14, 2012

Prominent Surgeons Call For Recall of Zimmer Inc. NexGen CR-Flex Knee Replacement

HOUSTON — Since 2003, more than 150,000 Zimmer NexGen CR-Flex knee implants have been sold, and an unprecedented number of patients who received the artificial knee system have experienced loosening, pain and other severe complications.

  The Zimmer NexGen CR-Flex knee system uses a porous, non-cement femoral component that attaches to the bottom of the thigh bone. In most knee replacement systems, a type of surgical cement is used to hold the component in place.

A recent study presented at the 2010 conference of the American Academy of Orthopedic Surgeons provided evidence that indicated the Zimmer NexGen CR-Flex knee replacement failure rate could be as high as nine percent, and suggested that the number of Zimmer knee implant complications that required revision surgery could be even higher. The same study found that 36 percent of Zimmer NexGen CR-Flex knee replacements became loose within two years of implantation. However, Zimmer has placed the blame on operating physicians and claimed that failures were caused by surgical errors, problems with the installation technique, or incompatibility with the type of patient who received the knee implant.

The study’s authors, Dr. Richard Berger and Dr. Craig Della Valle who hail from the Rush University Medical Center in Chicago, examined nearly 110 patients who received the Zimmer NexGen CR-Flex knee replacements. They discovered that nine patients needed a second corrective surgery due to knee pain and implant loosening, and that nearly 40 recipients showed signs of loose Zimmer knee implants which were unrelated to patient type, procedural approaches or specific surgeons.

Dr’s Berger and Della Valle have since called for a recall of Zimmer’s NexGen CR-Flex devices, to no avail. This may have something to do with the fact that the NexGen products made up two percent of Zimmer’s $1.76 billion sales in 2009.

Signs of a loose Zimmer Nex-Gen CR-Flex device may include: Knee stiffness, knee pain, limping, decreased range of motion in the joint, and difficulty putting weight on the knee. Over time, a loose knee implant can cause severe pain, erosion of the thigh bone, and severe restriction of a patient’s daily activities.

Due to these serious complications and the possibility of a Zimmer Nex-Gen CR-Flex knee replacement recall, potential lawsuits and class action claims are now being investigated and reviewed for individuals throughout the United States. It appears as though the manufacturer was aware of the risks associated with these devices, yet failed to take adequate steps to reduce instances of injury or warn consumers. Financial compensation may be available to those affected by Zimmer’s faulty Nex-Gen CR-Flex system.

 

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