Warsaw, IN (NursingSalary.org) – Prominent orthopedic surgeons are asking for the recall of Zimmer’s knee replacement device NexGen CR-Flex. The porous femoral replacement part “is associated with a high failure rate,” reports Miller & Zois.
Based on their clinical observations, Richard Berger and Craig Della Valle, two reputable surgeons from Chicago, assessed that the replacement is highly unreliable. After only two years of use, 36% of the implants loosened and 9.3% of the patients had to undergo corrective surgery.
“The failure rates are outrageously high,” said Dr Berger in an interview. “Acceptable rates are much lower than 10%—with similar devices from other manufacturers we usually have to do one correction per 20 patients. A failure rate higher than one third is horrific, to say the least. This component is still commercially available but should not be used for any patient!”
The exact reasons for the failure aren’t known yet, but experts suspect a flaw in design. The CR-Flex uses a ‘cementless’ and porous femoral component, where most cement-based products form the competition seem to work as they should.
A New York Times article tells us how Zimmer has been warned by the flawed devices they were selling, yet didn’t seem to care:
- When Dr Berger started complaining to Zimmer that the artificial knee was failing prematurely, Zimmer simply replied that it was a matter of Berger’s surgical technique, and not the implant’s problem.
- Two years ago, another top Zimmer consultant, Dr Lawrence Dorr, also alerted the company that a hip model was failing after only a couple of years, when it should have lasted for a lifetime and, similarly, Zimmer shot back saying it was Dr Dorr’s technique.
Zimmer has a history of recalling implants:
- In 2008, Zimmer had to recall their Durom Cup Replacement product after thousands of patients had received the implants. Patients complained with intensive pain after the normal healing period, and FDA’s verdict was that Zimmer had done a poor job with training surgeons. The product was released again after a few months and Zimmer started to offer extensive trainings and support.
- In June 2008, Zimmer issued a recall for the NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor, an instrument used during knee surgery. It was prone to getting broken during the procedure and could have potentially left metal fragments in the patient’s knee.
- A third recall was issued in 2008, this time for the Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, also due to the fact that it could break during surgery.
To read more on Zimmer Knee Replacement, visit our FDA Knee Replacement Recalls page.