Zimmer's Investigations

Response to U.S. Reports in 2008

In response to reports of cup loosening from U.S. surgeons, Zimmer conducted an investigation of the Durom Cup in 2008. The investigation included clinical and radiographic data review from users of the Durom Acetabular system. Zimmer visited 12 clinical sites, in both the U.S. and Europe, and examined more than 3,100 cases. As a result of its investigation, Zimmer concluded that the more successful users consistently execute crucial technique steps for Durom Cups in a specific manner.

The results of the investigation led Zimmer to conclude that additional surgical technique instructions and training were necessary in the United States. Zimmer voluntarily and temporarily suspended marketing and distribution of the Durom Cup in the U.S. while the company updated product labeling to provide more detailed surgical technique instructions. Zimmer also implemented a surgical training program for U.S. surgeons. During the 2008 investigation, Zimmer interviewed a number of surgeons in other countries but did not receive reports of similar revision rates outside of the United States. Continued monitoring of the effectiveness of the field action taken in the United States indicates the surgical technique modifications and associated training have been effective in mitigating the incidence of cup loosening.

Response to European Reports in 2009

In 2009, in response to isolated revision surgeries of the Durom/ Metasul® LDH® System in Europe, a task force was established to gather clinical data from users and investigate the performance of these devices outside of the United States.

The investigation included a thorough review of literature regarding the clinical performance of metal-on-metal devices, interviews with users of the Durom Cup in surface replacement arthroplasty (SRA) and total hip arthroplasty (THA) applications, and analysis of explants and laboratory testing of all components. During the investigation, Zimmer interviewed 52 users, in personal site visits or by phone, who collectively implanted 8,654 Durom Cups (81% in THA, 19% in SRA). Based on the results of this investigation, the most probable root cause for the reported revisions of loose acetabular cups was determined to be the use of a surgical technique which differs from that prescribed in the surgical technique for the Durom Cup.

As a result of Zimmer’s investigation, and in cooperation with regulatory agencies, the company voluntarily distributed updated surgical technique instructions and a mandatory DVD training module to all surgeons outside of the United States who utilize the Durom Cup in THA or SRA applications, to reiterate the importance of key steps in implantation.

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