General Information About Zimmer Hip & Knee implants
The Zimmer Durom Cup is a hip replacement material made with a single piece of material and is relatively new, having been introduced in 2006.
The Zimmer Durom Cup has been used in over 12 thousand patients since its 2006 introduction and has given rise to a reported complication rate, requiring replacement in over 5% of all patients. Although Zimmer has placed the blame for these complications on the backs of the surgical physicians, it appears that problems may have existed with the device since its original production.
In the summer of 2010, Senator Charles Grassley wrote to the President of Zimmer holdings, Mr. David Dvoarak, setting forth concerns he had with the Zimmer NexGen CR-Flex knee implant. In a New York Times article, two Zimmer expert consultants had raised concerns over the NexGen CR-Flex knee implant, which Zimmer had discounted. In fact, Dr. Rcihard Berger, a long time expert consultant who had earned over $8 million dollars while working with Zimmer, had voiced significant concern over the device.
Senator Grassley set forth a series of questions concerning Zimmer and its products in general:
- What process does Zimmer have in place to respond to allegations and concerns raised by its consultants or contractors regarding the safety of one of its products?
- Since January 2008, how many Zimmer consultants or contractors have raised safety concerns or problems regarding Zimmer’s products?
- Of the safety concerns or problems identified since January 2008, how many were refuted by Zimmer?
- Does Zimmer voluntarily collect data on the performance of its hip and knee devices and other implantable devices? If so, how is that data collected? If not, has Zimmer considered putting in place a process for tracking and reviewing the performance of its devices?
The Zimmer Durom Cup and the Zimmer NexGen CR-Flex knee implant have both been accused of having manufacturing or design problems, but have not been recalled by the Food & Drug Administration. Should patients who had these devices placed in their bodies be concerned? Only if you suffer from continued pain or if you have developed pain within (3) years after your surgery should you be concerned.
If you do require replacement of either the Zimmer Durom Cup or the Zimmer NexGen CR-Flex knee implant, ask your doctor to hold the removed device for safekeeping and to NOT return the implant to the manufacturer. Ask your doctor to inform you for the reason of the joint failure and to set forth in a letter to you his or her opinions.
Consult with an attorney who is handling medical device cases in order to evaluate whether you have a case of medical device failure and tyo advise you of your best options.