By Andrew SulloSullo & Sullo LLP
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.
