A number of parts used in the Zimmer NexGen Complete Knee Solution MIS procedure were quietly recalled last year after numerous reports of failure.
On September 13, 2010, a Zimmer NexGen knee recall was issued for NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels, according to information in an FDA medical device recall database.
The recall went widely unreported, without any apparent FDA alert or press release issued by Zimmer. Information about the recall on the FDA’s website was just updated on March 28, 2011.
At least 114 reports of Zimmer NexGen knee problems have been associated with the recalled components, according to information posted by the FDA in connection to the recall. Problems included reports that the Zimmer NexGen knees had loosened and that patients had to undergo additional knee surgery to have the devices replaced.
The FDA also indicates that on April 26, 2010, Zimmer sent a letter to healthcare facilities and customers who had bought the device to destroy or disregard all previous guides on the surgical techniques needed to install the implants and sent out revised surgical guides.
The Zimmer NexGen recall affected 68,384 knee components, which were distributed in 13 states across the U.S.
A number of Zimmer NexGen knee replacement lawsuits have been filed on behalf of individuals who have received devices manufactured by the company, most involving the Zimmer NexGen CR-Flex knee, which does not appear to be involved in this Zimmer knee recall.
Last year, concerns about problems with the Zimmer NexGen CR-Flex knee were raised by Dr. Richard A Berger, a former consultant for the manufacturer. Dr. Berger complained that the adhesive-free version of the Zimmer knee implant was not fusing to patients’ bones as it should.
Zimmer dismissed Dr. Berger’s concerns, canceled their relationship with the orthopaedic surgeon and claimed that the problem lay in his surgical skills. This came after the company reportedly paid Dr. Berger $8 million over a 10 year period to work as an orthopedic consultant.
Dr. Berger and another surgeon presented a study at the American Academy of Orthopaedic Surgeons annual conference in New Orleans in March 2010, which suggested that the Zimmer NexGen CR-Flex knee replacement problems resulted in nearly a 10% failure rate.