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Problems with Zimmer NexGen Knee Implants

Why Are Problems Claimed with Zimmer NexGen CR Flex Cementless Porous Femoral Head Knee Implant Device Surgeries? Is it the Device or Surgeon?

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Why Are There Problems With Certain Zimmer Knee Implant Surgeries? That is essentially what people are asking us. These people or their family members have suffered extreme pain and suffering and the need for knee revision surgery sooner than originally advised after knee implant surgery. The question is why? Was it a device failure or a problem with surgical technique?

Likewise, U.S. Senator Grassley wrote a letter to Zimmer Holdings, Inc., the manufacturer of Zimmer NexGen knee systems asking for better disclosure as to how the company handles complaints and how many did the company refute.

On Capitol Hill now there is a debate going on as to whether or not the FDA regulation of medical devices is too lax or too cumbersome. If you had a Zimmer knee revision surgery - your medical records could help reveal the answer as to whether it was the device or something else that caused the failure and need for revision. If it is the device, should the FDA be more careful in its approval of these products? Tell us what you think.

According to some doctors and researchers, medical device regulation is too lax. But to many medical device makers and certain politicians, the process is too slow and overregulated. What do you think? Is it OK for a device to be approved without further study, by simply relying on the approval of a prior design that is somewhat similar?

According to testimony by a doctor at the Cleveland Clinic, 71% of the 113 class I (highest-risk) recalls of medical devices between 2005 and 2009 were for devices cleared through the 510(k) premarket notification process. The 510(K) process does not require new clinical data or clinical trials when device makers don't reinvent, but merely claim to improve, existing products.

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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. Not all Zimmer NexGen products are involved in our investigations and lawsuits.