In 2003, Zimmer Holdings introduced the NexGen CR Flex artificial knee implant. Since that time, more than 150,000 of the joints have been sold. The NexGen accounted for approximately 2% of the company’s $1.76 billion in sales in 2009. In a financial sense, the NexGen is a successful medical product, but two orthopaedic surgeons from Chicago, Dr. Richard Berger and Dr. Craig Della Valle, both with Rush University Medical Center, are seeking its recall. Their concerns have now caught the attention of the United States Senate.
Both physicians have used the implant extensively and claim that in their experience, 36% of NexGen knees loosen within two years of implantation and 9.3% require revision surgery for associated pain and mobility issues. In response to Berger and Della Valle’s claims, Zimmer has said both surgeons have simply positioned the devices incorrectly.
While Zimmer’s dismissive response ignores the skill and experience of both men, the claim is particularly interesting in the case of Dr. Berger who worked for Zimmer for more than ten years as a consulting surgeon, trainer, and joint designer of both knee and hip implants. That professional relationship was severed when Zimmer took his call for a voluntary recall of the NexGen public, but during the time he was associated with the manufacturer, Berger reportedly earned more than $8 million.
A report by Barry Meier, “Surgeons vs. Knee Maker: Who’s Rejecting Whom?” in the June 18, 2010 issue of The New York Times prompted Sen. Charles E. Grassley, the ranking member of the Senate Committee on Finance to contact Zimmer CEO David C. Dvorak by letter on July 29, 2010. The Committee, among its other duties, oversees both Medicare and Medicaid.
Grassley asked for several pieces of information including a list of Zimmer consultants or contractors who have raised concerns about the safety of the company’s products since January 2008. Additionally, Grassley asked how and if Zimmer voluntarily collects data on the performance of its hip and knee implant products.
In a statement, Zimmer said it welcomed a discussion with the committee regarding the NexGen. “For decades, Zimmer engineers and health care professionals (HCPs) have worked closely to develop technologies that match patients’ needs and improve clinical outcomes in musculoskeletal care . . .,” the statement read in part. “Beyond product development, Zimmer welcomes and seeks feedback from surgeons who use our products. This feedback can lead to modifications and improvements to products, their labeling and the manner in which we train and educate surgeons about our products.”
As a Seattle knee recall lawyer I suggest you seek medical advice and contact a personal injury lawyer if you have a NexGen knee implant.