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Our attorneys are reviewing claims of people who underwent knee replacement surgery with the Zimmer NexGen® CR-Flex, NexGen® LPS-Flex or NexGen® Complete Knee Solution MIS Tibial Components and suffered pain or other side effects indicative of failure of the device or had to have the device replaced in a revision surgery.
Side effects that may be indicative of a Zimmer NexGen CR-Flex, NexGen LPS-Flex and NexGen Complete Knee Solution MIS Tibial Components failure:
Doctor paid by Zimmer warned the company about problems with the NexGen CR-Flex device:
The New York Times has reported that Dr. Richard A. Berger, who worked for Zimmer Inc. designing surgical tools and artificial joints and who trained other doctors how to use the devices, warned Zimmer about problems with the NexGen CR-Flex in 2006.(1)
Dr. Berger was a top consultant for Zimmer, earning more than $8 million from the company over the course of their decade long relationship. Of about 1000 hip and knee replacement surgeries Dr. Berger performed each year, he used Zimmer devices in nearly all of them.
In 2006, when he began to see loosening problems with the NexGen CR-Flex in patients implanted with the device the year before, he notified Zimmer. He notified them again when he later had to replace some of the devices and the company implied that the device failures were due to his surgical technique and not a problem with the device necessitating a NexGen recall.
Dr. Berger then collaborated with Dr. Craig Della Valle, both of Rush University Medical Center, in a study of 108 of their patients implanted with the NexGen CR-Flex device. Nine (8.3%) of their patients experienced pain and loosening that required surgery to replace the failed NexGen CR-Flex device and 39 (36%) patients showed evidence of radiographic loosening of the device.(2) Zimmer did not issue a NexGen recall after reviewing results of this study.
Senator Charles E. Grassley found the article in the New York Times so alarming he wrote a letter to David Dvorak, President and Chief Executive Officer of Zimmer Holdings Inc., demanding answers.(3)
Zimmer has stated it investigated Dr. Berger’s claims and disagreed with them. The manufacturer claims that post-market data from the Australian market show the NexGen CR-Flex has a low revision rate. No one in the U.S. tracks long-term performance of knee replacement devices.
Many people with a Zimmer knee replacement may be confused by incorrect or misleading information on the internet about a Zimmer NexGen recall.
As of October 30, 2011, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database has recorded:(4)
Despite these reports of failures of the Zimmer NexGen CR-Flex, NexGen LPS-Flex and NexGen Complete Knee Solution MIS Tibial Components, the manufacturer has not issued a total NexGen recall.
In September 2010, Zimmer issued a NexGen recall only for the NexGen Complete Knee Solution MIS Tibial Components.(5) According to the FDA recall notice, the manufacturer received 114 Medical Device Reports (MDRs) of patients with this device who needed a revision surgery to replace the implant because it had become loose.
However, this NexGen recall did not take NexGen Complete Knee Solution MIS Tibial Components off the market. The manufacturer instead revised the implant’s Surgical Technique and Instructions for Use to warn doctors they should fully cement surfaces of the tibial component and recommend they use of a drop down stem extension.
If you have had a Zimmer knee replacement involving any of these devices and experienced side effects associated with device failure, our New York defective product attorneys want to speak with you.
Zimmer Inc., the manufacturer, did not test these Zimmer knee replacement devices in people to determine if they were safe before placing them on the market because they indicated to the U.S. Food and Drug Administration (FDA) that the implants were substantially equivalent to a device already approved for use.
You may have valuable legal rights. Our attorneys are offering a free legal consultation to people injured by any of these Zimmer knee replacement devices. You may have a case even if Zimmer has not issued a NexGen recall.
We help people injured by defective medical devices hold the manufacturers responsible. Contact one of the experienced attorneys at Proner & Proner if you are thinking about filing a Zimmer NexGen knee replacement lawsuit in NY or anywhere else in the United States.
(1) New York Times. (2010, June 19). Surgeon vs. Knee Maker: Who’s Rejecting Whom? Retrieved October 30, 2011, from http://www.nytimes.com/2010/06/20/business/20knee.html?pagewanted=1
(2) Zimmer Holdings, Inc. (2010, March 11). Statement on the Zimmer NexGen® CR-Flex Porous Femoral Component . Retrieved October 30, 2011, from U.S. Securities and Exchange Commission (SEC): http://sec.gov/Archives/edgar/data/1136869/
(3) Grassley, Senator Charles E. (2010, July 29). Letter to Zimmer Holdings, Inc. Retrieved October 30, 2011, from www.NYTimes.com: http://graphics8.nytimes.com/packages/pdf/business/device-letter.pdf
(4) U.S. Food and Drug Administration (FDA). (2011, October 30). MAUDE – Manufacturer and User Facility Device Experience. Retrieved October 30, 2011, from www.FDA.gov: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/textsearch.cfm
(5) Zimmer, Inc. (2010, September 13). Class 2 RecallNEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS. Retrieved October 30, 2011, from www.FDA.gov: http://www.accessdata.fda.gov/scripts/cdrh
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