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FDA required no new clinical data for certain Zimmer NexGen knee systems to be approved

Did you know that the FDA required no clinical data for Certain Knee Systems to be Approved?

knee implant

For example, according to the 2005 510(K) premarket notification clearance from the FDA for Zimmer NexGen MIS Tibial Components:

  • "are part of the NexGen system of semi constrained, non linked condylar knee prostheses. (MIS means minimally invasive surgery.)"
  • Except for minor modifications, MIS Tibial Components are identical to the predicate devices. The modifications do not change the intended use or the fundamental scientific technology. (In this case, predicate means previous.)
  • Non-Clinical Performance and Conclusions: and/or Clinical):

Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

  • "Clinical data and conclusions were not needed for this device."

Judge for yourself by reviewing the FDA MAUDE database. There you will find the details of hundreds of reports for various knee replacement systems. For searches matching "ZIMMER" and "NexGen" you will find the following numbers of reports.

Year# of events reported
2011 14a/o January
2010417
2009436
2008321
2007154
200660
200560
200442
200331

And for searches with certain keywords, the MAUDE system shows the following for 2003-2011

Events contained the word "removal"254
Events contained the word "removed"142
Events contained the word "loose"448
Events contained the word "explants"11

Are all of the knee systems approved by the FDA safe and effective? As to a certain Zimmer product, the NexGen CR Flex Cementless Porous Femoral Component, this is a question raised by the study published by Dr. Berger and written about in the NY Times. See, "The High Failure Rate of a High-Flex Total Knee Arthroplasty Design" and "Surgeon vs. Knee Maker: Who's Rejecting Whom?".

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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.