Zimmer Turns on Dr. Berger with Reports that the Zimmer NexGen Knee Has a High Failure Rate
Melissa HagueJanuary 18, 2011 9:24 AM
Instead of taking responsibility for distributing defective products that are causing harm to consumers, Zimmer has taken the approach of blaming its own consultants. First it was Dr. Dorr with the Zimmer Durom cup and now its Dr. Berger with the Zimmer NexGen knee.
In April 2008, Dr. Dorr, a Zimmer consultant for its Durom cup hip prosthetic, expressed concerns about the product because he was finding an exceedingly high failure rate with the hips. Zimmer then conducted its own investigation and three months later decided to “suspend sales” of its Durom cup. Zimmer issued a statement that it was not recalling the product and that it did not find any “manufacturing defect or design defect” with the hip prosthetic. Instead, Zimmer blamed the high failure rate on its own doctor’s surgical technique.
Zimmer has once again turned its back on one of its consultants who Zimmer has paid more than $8 million over the period of a decade. Dr. Berger was one of Zimmer’s number one surgeons utilizing Zimmer’s NexGen knee product line. Zimmer proclaimed Dr. Berger as a master surgeon and Dr. Berger trained hundreds of surgeons on behalf of Zimmer. However, after Dr. Berger expressed concerns to Zimmer that certain NexGen knee implants were ematurely failing in his patients, Zimmer conveniently did not renew its longstanding consulting agreement with Dr. Berger.
Last March, Dr. Berger presented results of his study to the American Academy of Orthopaedic Surgeons, where he found a 9% failure rate with that particular model of Zimmer NexGen knee. That implant was loosening and causing pain only two years after it was implanted and requiring patients to undergo revision surgery. Dr. Berger called for the product to be recalled, saying that it “should not be used in any patient.”
Zimmer’s response was to blame Dr. Berger’s surgical technique, just as it did with Dr. Dorr. Zimmer spent years boasting about Dr. Berger’s superior surgical ability and paid him millions of dollars to train other surgeons. Now that there is evidence their NexGen knee is failing, Zimmer claims there is nothing defective with their product and the failures are due to Dr. Berger’s technique. This is the same surgical technique Zimmer prided itself on for years. Zimmer’s repetitive failure to accept responsibility has seriously put into question it’s credibility. Zimmer’s actions speak volumes as to their priorities. Zimmer’s number one priority is its sales and profits, and when it comes to their NexGen product, this is in direct conflict with the health of its consumers.
Related article: http://www.nytimes.com/2010/06/20/business/20knee.html
Product Identification Notice: In any of our web pages referring to Zimmer NexGen products, these pages are intended to provide information about and are referring to the same Zimmer products that were identified by Dr. Berger in his presentation and study entitled "The High Failure Rate of a High-Flex Total Knee Arthroplasty Design," and were written about in the NY Times article titled "Surgeon vs. Knee Maker: Who’s Rejecting Whom?," and that are reported in the FDA MAUDE database, where reports involving the Zimmer NexGen CR Flex Cementless or Porous Femoral component can be found and also those products associated with aseptic loosening of the Zimmer MIS Tibial Component that led certain doctors to discontinue its use, and to recommend discontinued use of this product in primary TKA until the etiology of the high early failure rate of this implant is determined. See prospective studies comparing the results of the Zimmer MIS Tibial Component using conventional and minimally invasive exposures as well as comparing fixation with different types of bone cement as described in Early Aseptic Loosening With a Precoated Low-Profile Tibial Component A Case Series. Not all Zimmer NexGen products are involved in our investigations and lawsuits.