Zimmer NexGen Knee Recall
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New Jersey Zimmer NexGen Knee Recall Lawsuits

Zimmer NexGen Knee Problems

Orthopedic Surgeons Claim Zimmer NexGen Knee Problems Go Beyond Recalled Components, Studies Showing Higher Than Usual Failure Rate

Zimmer NexGen Knee Problems
While more than 65,000 Zimmer NexGen Knee Replacement components have been recalled, there are many more Zimmer NexGen knee systems in use today. At the recent American Academy of Orthopaedic Surgeon conference in March 2010 there were multiple orthopedic surgeons presenting their studies of problems with various Zimmer NexGen Knee Replacement Systems problems.

Additionally, Senator Charles Grassley of the U.S. Senate Finance Committee, which has jurisdiction over Medicare and Medicaid programs that provides healthcare coverage to over 100 million Americans, weighed in on Zimmer knee problems in June of 2010 with a letter to Zimmer's President and CEO after reading the New York Times article "Surgeon vs. Knee Maker: Who's Rejecting Whom" regarding a respected orthopedic surgeon's allegations of one of Zimmer's NexGen knee replacement systems problems. Senator Grassley questioned Zimmer's handling of Zimmer NexGen knee problems and the company's relationships with paid consultants.

Prominent publications such as the New York Times and the British Journal of Bone and Joint Surgery have published the results of studies that have shown that as many as 20% or more of Zimmer NexGen Legacy Posterior Stabilized (LPS) Stabilized-Flex Fixed total knee replacements become loose at the femoral component and require revision surgery to be corrected. The most common Zimmer NexGen knee problems include loosening, resulting in pain and stiffness in the knee, osteoarthritis, instability (mobility and stability are the primary functions of a healthy knee), infection, dislocation and persistent pain.

NexGen CR-Flex Porous Knee Replacement System Problems

Zimmer NexGen knee problems were first brought to the public spotlight in the June 2010 New York Times article "Surgeon vs. Knee Maker: Who's Rejecting Whom"
which detailed the dispute between Zimmer and prominent orthopedic surgeon Dr. Richard A. Berger. The New York Times reported that in March of 2010, Dr. Berger presented the results of a study showing about a 9% failure rate of Zimmer NexGen CR-Flex Porous knee replacement systems that required revision, or replacement, surgery. Zimmer vigorously denies this allegation, as well as Dr. Berger's other claim that another 36% of those in his study showed loosening of the implant but not to the point of requiring revision surgery. The article went on to state that Zimmer's response after Dr. Berger brought the NexGen knee problem to their attention in 2006 was to blame his procedures, somewhat hypocritically since Dr. Berger was one of Zimmer's most praised and highly paid consultants (more than $8 million over a ten-plus year period) who had trained hundreds of surgeons in his advanced techniques. This article even led to an inquiry from the U.S. Senate (see U.S. Senate Finance Committee Questions Zimmer's Corporate Behavior below).

NexGen Legacy Posterior Stabilized (LPS) Flex and Flex Fixed Knee Problems

The British Journal of Bone and Joint Surgery published the findings of two professors at the Department of Orthopaedic Surgery at Seoul National University College of Medicine regarding what the article called a "high incidence of loosening of the femoral component in the (Zimmer NexGen) legacy posterior stabilised-flex total knee replacement". This article stated that 38% of the patients in their study had loosening of the device in less than 3 years and 21% required surgery to correct the problem in less than 2 years.

U.S. Senate Finance Committee Questions Zimmer's Corporate Behavior

When Senator Charles Grassley, the Ranking Member of Senate Finance Committee at the time, sent a letter to the President and CEO of Zimmer, Inc. on July 29, 2010, he raised questions about what the New York Times article might indicate was a pattern of ignoring the concerns of medical professionals over select devices marketed by the company. Senator Grassley's letter to Zimmer did not focus on the NexGen knee replacement systems, but rather the company's overall policies for ensuring that its devices are safe. In that letter he also referenced Zimmer's deferrered prosecution agreement with the Department of Justice and the requirement that Zimmer be more transparent in its dealings with consultants.

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