Zimmer, a manufacturer of a variety of medical implant devices, has recently come under fire for problems associated with one of its many products, the NexGen CR-Flex Porous Femoral component of its knee replacement systems, primarily with claims of premature failure. The data about this particular Zimmer NexGen knee product was raised by Dr. Richard Berger at the 2010 Annual Meeting Podium Presentations in a presentation titled Adult Reconstruction Knee 3: Outcomes of Total and Unicompartmental Knee Replacements – The High Failure Rate of a High-Flex Total Knee Arthroplasty Design. The CR-Flex system is designed to adhere to the patient’s bone without the use of adhesive cement. The device fuses to the femur, or in some cases the tibia, bone through the use of cobalt-chromium-molybdenum alloy and porous fiber metal that mimics human bone.
Counsel for Zimmer points out that Dr. Berger’s study relates to only 108 cases, and only to the NexGen CR-Flex Porous Femoral component, which is used in less than 4% of all NexGen cases. The NexGen brand encompasses a variety of components, the vast majority of which are not the subject of the study referenced above. For example, the many different NexGen systems and components not studied by Dr. Berger, including the NexGen CR; NexGen CRA; NexGen LPS; NexGen LPS-Flex; NexGen LPS-Flex-Fixed; NexGen LPS; NexGen Legacy LPS; ad the NexGen LCCK products.
Concerns over the knee implant device appear to date back as far as 2006, when one of Zimmer’s own surgeon consultants, Dr. Berger, raised concerns to the company over the device’s premature failure. According to the NY Times, in 2006, Zimmer rejected Dr. Berger’s claims as unfounded, blaming the surgeon’s technique, and not the device, for the failures.
Further, Zimmer’s counsel cites to the 2010 Australian Orthopaedic Association National Joint Replacement Registry 2010 Annual report Table KT30, pg 123 and the Swedish Knee Arthroplasty Register, Annual Report 2010, pg 30 in asserting that, Dr. Berger’s results are highly atypical and that Dr. Berger’s results stand in stark contrast to other publicly available information concerning the NexGen family of products.
However, Dr. Berger has publicly backed his concerns with a study that demonstrate the implant device’s problems. Specifically, Dr. Berger indicates that beginning in 2005, he used the Zimmer NexGen CR-Flex device with 125 patients. The device is projected to last 15 years, but Dr. Berger stated that it had already begun failing in a number of patients in just one year. In the actual study that Dr. Berger conducted with Dr. Craig Della Valle, the particular Zimmer device in the study is stated to have failed completely within two years in 9.3% of patients, and to have exhibited signs of loosening in approximately 36% of patients. Over half of the 100 patients in the study a reported to have experienced knee pain and other problems from loosening of the implant. Overall, the study reported that patients with the implants commonly experience:
- Device Failure
- Need for Revision Surgery
- Loosening of Implant Components
- Knee Pain
- Compensation Pain and Problems
Since the release of that study and The New York Time article, Zimmer has come under some scrutiny for its handling of the safety concerns. In a letter dated July 29, 2010, Senator Charles Grassley, in his capacity as member of the Senate Committee on Finance, requested information from Zimmer regarding: the procedures that Zimmer has in place to respond to safety allegations and concerns raised by its consultants; which Zimmer consultants have in fact raised safety concerns about Zimmer products; how those concerns were dealt with; and whether Zimmer collects data on the performance of its devices.
According to Zimmer’s counsel, following the publication of the Article in the New York Times, in July 2010, Zimmer received an inquiry from Senator Charles E. Grassley, then Ranking Member of the United States Senate Committee on Finance, regarding the Zimmer product assurance and complaint handling systems. Zimmer’s counsel states in a letter dated March 17, 2011 that,
"Zimmer cooperated fully with the inquiry, emphasizing its rigorous quality programs and product complaint handling, in general, and its handling of the failures reports by one surgeon cited in The New York Times article, in particular. Zimmer can confirm that, following meetings with Senator Grassley’s Committee staff, the Company has received notice that it has satisfactorily responded to all of the Committee’s requests pertaining to its Complaint handling system and the facts and circumstance of the specific complaints under review. The Committee staff has indicated that Senator Grassley has no further questions or requests."
In a separate matter, in September of 2010, the FDA issued a Class 2 recall of certain components of the NexGen Complete Knee Solution MIS (Class 2 Recall NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS). The device is often used for patients with severe pain and disability that have resulted from certain types of arthritis, trauma, collage disorders, and deformities. The recall comes after Zimmer had received complaints of the implant device loosening, which in turn required a second, revision, surgery for the affected patients.
Related: For Other Articles on Zimmer NexGen Knee
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.