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Background
The Durom Cup is a special cobalt-chromium metal acetabular implant that was first developed in the UK and has been in use there since 2001 (principally used in hip resurfacing, a less extensive form of hip replacement). In the US, a different version of the device for total hip replacement was introduced in 2006.
Early Warning
The Australian Orthopedic Association's National Joint Replacement Registry 2007 report showed storms could be on the horizon. It stated the Durom Cup had twice the risk of revision. On April 22, 2008, one of the nation's most prominent orthopedic surgeons, Dr. Larry Dorr, M.D., sent a letter to his colleagues because the Zimmer Company refused to listen. In the letter he stated:
"The company does not believe it should pull the cup from the market so I am notifying all of my colleagues of our failure rate with this cup. "
"...we performed revisions on 29 patients (30 hips [15%]) with 21 of 29 (72%) having radiographic criteria of loosening. Thirteen retrieved cups and acetabular tissue were examined histologically. Twenty-eight of 151 unrevised patients had radiographic impending failure; 12 without revision had clinical failure. Eight patients (nine hips) had both clinical failure and impending radiographic failure."
The reaction of Zimmer has been to blame the surgeons. However, even their analysis demonstrates a highly increased failure rate. Even Zimmer's own study demonstrates that the device is defective.
As a result of being implanted with defective hips patients are required to undergo a second surgery. All of their rehabilitation efforts from the first surgery were in vain.
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