The reason for the FDA's recall of Zimmer NexGen complete knee solution MIS total knee procedure stemmed tibial component is eerily similar to problems now facing Zimmer with its NexGen CR-Flex artificial knee replacement: Zimmer received complaints of loosening of the implanted device requiring revision surgery.
According to the FDA, of 114 MDRs (medical device reporting) filed, all of them reported that the NexGen MIS device loosened and the patient required additional surgery to replace the device. The FDA issued the recall based on a 2010 study by two orthopedic surgeons who reviewed the NexGen MIS revision and failure rate. They determined that MIS Tibias placed without a stem component failed 24 percent of the time, compared to those with stem components which failed only 4.2 percent.
This recall leads to two obvious questions: What other Zimmer Knee Implants have these problems, and should all Zimmer artificial knees be recalled?
Zimmer doesn't have a good track record: In 2008, the manufacturer suspended sales of its Durom Cup, until it could "update the label with instructions about special surgical techniques to be followed during total hip replacements."
And just like its Durom Cup, Zimmer is blaming surgeons rather than considering that the Zimmer NexGen CR-Flex is defective. Zimmer issued a statement that negated the findings of Doctors Berger and Valle, who claimed that "loosening and revision [of Zimmer's NexGen CR-Flex Porous Femoral component] were not related to surgeon, approach or patient type." Rather, the company claimed that the surgeons simply implanted their devices incorrectly, and noted that the Australian National Joint Replacement Registry revealed a high success rate.
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Zimmer has good reason for concern. According to a filing with the Securities and Exchange Commission, Zimmer sold more than 150,000 Zimmer NexGen knee implants since 2003. Furthermore, the NexGen products made up 2 percent of the company's $1.76 billion sales in 2009. Perhaps the company might want to squirrel away some of its profits for NexGen lawsuits—recall or not.