No NexGen Recall Yet, Though Complaints Continue to Mount

No NexGen Recall Yet, Though Complaints Continue to Mount

Zimmer first marketed the NexGen line of knee replacement systems for sale in the mid-1990s. Although the products in the NexGen line have been successful for the most part, there are some concerns with its latest device. The cementless version of the NexGen CR-Flex, which attaches to the thighbone through natural ingrowth, is the subject of the complaints. The device has reportedly been prematurely loosening in patients after just a few years of use, causing serious pain whenever the patient simply extends his or her leg.

A big part of the blame in the court of public opinion has fallen on the shoulders of the U.S. Food and Drug Administration (FDA), the governmental body responsible for approving the device for sale to the public. Most of the criticism toward the FDA is regarding one of the methods by which it approves for sale medical devices like the NexGen CR-Flex. The 510(k) approval process, which is how the CR-Flex was deemed appropriate for sale, allows approval of devices that are "substantially similar" to other already approved devices without requiring pre-market testing.

While the FDA asserts that the process is beneficial in that it encourages companies to continually improve their already developed products without being hampered by needless regulation, the lack of testing and subsequent failure of devices is evidence that the process should be reformed. There are additional criticisms with the FDA's oversight of the medical device industry. The United States Government Accountability Office released a report last year finding that the FDA does not regularly conduct appropriate inspections of medical device manufacturing facilities. The report also stated that the post-market surveillance of already-approved products is insufficient to ensure public safety.

This is an alarming finding given that if the FDA is going to encourage innovation through under-regulation, it is very important that it closely monitors the safety of products approved through the process. The health of the 21 million people who suffer from osteoarthritis of the knees in the United States is at stake. The companies that make billions of dollars on the sale of these products cannot be allowed to let the bottom line completely drive the process of releasing these devices to market.

Although there has yet to be a Zimmer NexGen knee recall, there could be one in the future if the evidence that the product is prone to failure continues to build. The attorneys at the Rottenstein Law Group have a total of over 25 years of experience helping clients who have been harmed by negligent companies like Zimmer.

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