Since we last wrote to you in May 2008 regarding the Durom® Acetabular Component (“Durom Cup”), Zimmer has completed an extensive investigation of clinical experience with this product and its conformance to specifications. We are able at this time to share with you key conclusions and actions with respect to the Durom Cup in the United States.
- The results of our in-depth investigation have led us to conclude that additional surgical technique instructions and training are necessary in the United States, and we strongly recommend that U.S. surgeons stop implanting the Durom Cup until receiving such training.
- Zimmer will suspend marketing and distribution of the Durom Cup in the U.S., while we update product labeling to provide more detailed surgical technique instructions and implement a surgical training program for U.S. surgeons.
- The Durom Cup will continue to be marketed and distributed without interruption outside the U.S.
Our investigation included clinical and radiographic data review from users of the Durom Acetabular system, including those who have been pleased with their results, as well as users who are experiencing a higher than desired rate of revision.