Zimmer NexGen CR-Flex Knee Model Under Scrutiny by Senator Grassley

Zimmer NexGen CR-Flex Knee Model Under Scrutiny by Senator Grassley

The Zimmer NexGen CR-Flex knee replacement system has been the subject of criticism of late. Some sources have shown evidence that the NexGen CR-Flex, which attaches to the thigh bone through natural bone ingrowth rather than cement or screws like many other medical devices, is failing at a rate that is unacceptable by industry standards. Many patients have come forward with complaints that they have suffered loosening in their device, some even requiring revision surgery. While it is up in the air right now whether there is a fundamental flaw in the Zimmer NexGen CR-Flex, there are some who believe it is a very real possibility.

Concerns with the NexGen CR-Flex have even led to Iowa Senator Chuck Grassley to write a letter to Zimmer's Chief Executive Officer, David Dvorak, calling for more transparency in how the company handles adverse reports internally. In the letter, Senator Grassley asked the CEO to provide a list of all safety concerns reported by consultants since January of 2008, and the company's response to each. Zimmer gave its response to Senator Grassley, explaining the details of the company's "post-market surveillance program," which is "designed to ensure the well-being of patients and address the concerns of surgeons responsibly and appropriately."

The U.S. Food and Drug Administration (FDA) first approved NexGen CR-Flex using the controversial Section 510(k) approval process, in which approval is based on substantial similarity to other previously approved medical devices. A study conducted by three professionals at the National Research Center for Women and Families examined the 113 high-risk medical device recalls ordered by the FDA from 2005-2009. 71% of the devices recalled were initially cleared through the 510(k) process, while only 19% were initially approved through the more rigorous Premarket Approval Application. Clearly, there is an increased risk of failure in devices such as the Zimmer NexGen CR-Flex that are approved through the 510(k) process.

Zimmer Holdings, Inc. is one of the world's largest manufacturers of medical devices, reporting profits of nearly $600 million in 2010, though that number is down from their reported profits of over $700 million in 2009. Here we have an industry giant that seems to be negligently marketing dangerous medical devices to the public. Accountability needs to be increased in the medical device industry, and those who have been harmed by negligent companies have to come forward in order to effect real change.

If you have had a Zimmer NexGen CR-Flex knee model and have suffered loosening, pain, or had to undergo revision surgery, you could be entitled to a claim against Zimmer. In order to determine if your situation should give rise to a Zimmer lawsuit, look no further than the Rottenstein Law Group. The lawyers at RLG have 25 years of experience of taking on negligent companies on behalf of the people they have harmed.

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