Zimmer Durom Cup
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Zimmer Durom Cup
Zimmer Inc. is a well known manufacturer of orthopedic prostheses and in particular replacement joints for hips and knees. They have been in business for eighty years and in 2006, received FDA approval to market their new artificial hip under the name “Durom.” Zimmer has had its share of troubles with artificial hips; in 2001 they were forced to recall a product with a ceramic head (or ball, as in ball and socket joint) because in too many cases it was disintegrating shortly after surgical installation.
In July of 2008 Zimmer chose to voluntarily recall its Durom product because of severe criticism from a prominent California orthopedic surgeon and joint replacement specialist. Dr. Larry Dorr is considered to be an opinion leader in hip and joint replacement surgery and operates a clinic dedicated to the field. Dr. Dorr found that 14 of the 165 Durom hip systems implanted at his clinic needed additional surgery within two years. He sent out an open letter to his colleagues that described in graphic detail what he found when he performed “revision” surgery to correct the painful problems his patients were having with their Durom artificial hips.
Specifically Dr. Dorr addressed the Durom cup (or socket, as in ball and socket joint) which seemed to have an inadequate design for firm attachment to the body. In particular he described finding one Durom cup which had migrated within the body away from its placement site. Other instances of revision surgery revealed Durom cups that easily detached from their positions. Dr. Dorr’s stature within the profession is such that his letter prompted Zimmer to cease sales of the Durom cup in the United States.
Even while voluntarily recalling their own product Zimmer claimed that Durom cup failures were due to inadequate surgical techniques on the part of U.S. surgeons. They have proclaimed their intention to institute a “training program” for practicing MDs who replace hip joints so that they may learn how to properly ply their trade with Zimmer’s Durom replacement hips. They will also be amending the literature that ships with each packaged product that explains how to install a Durom cup.
Zimmer claims that the Durom hip has been in circulation in Europe since 2003 and few problems have been encountered. However 12,000 Durom hips have been implanted over the two years that they’ve been on the U.S. market and there have been enough reports of problems to prompt a recall in this country. For the moment, Zimmer’s actions speak louder than their disclaimers with regard to the Zimmer Durom cup recall.
