Frequently Asked Questions

Why did Zimmer suspend marketing and distribution of the Durom Cup?

In response to reports of revision surgeries from some U.S. surgeons, Zimmer conducted an investigation of the Durom Cup in 2008. 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 surgeons.

Was the Durom Cup found to be defective?

After a thorough investigation, Zimmer concluded that the Durom Cup is not defective. Zimmer is confident that the Durom Cup is safe and effective when used as intended.

How many surgeons were interviewed as part of Zimmer’s investigations?

In its 2008 investigation, Zimmer visited a total of 12 clinical sites, examining more than 3,100 cases. Zimmer interviewed surgeons in both the U.S. and Europe but received reports of higher than expected revision rates only in the United States.

During a 2009 investigation into isolated reports from Europe of revision surgeries in Durom Cup patients at European hospitals, Zimmer interviewed 52 surgeons who collectively implanted 8,654 Durom Cups.

What are the clinical implications for affected patients?

Some surgeons have reported a higher than expected rate of cup loosening with the Durom Cup, which has resulted in revision surgeries. Pain can result from the loosening of the implant. The main symptom of loosening is pain radiating from the hip or groin area. However, patients should keep in mind that hip replacement surgery is a very invasive procedure, and a certain amount of pain shortly after surgery is expected. If patients experience pain more than three months after surgery, they should make an appointment with their surgeon.

Do patients already implanted with this system require revision?

Patients should schedule routine follow-up evaluations with their surgeons to assess their clinical progress towards recovery.

What training does Zimmer require of surgeons using the Durom Cup?

All new users of the Durom Cup are required to complete a mandatory online training course and/or training DVD prior to being supplied with the product. Continued monitoring of the effectiveness of field actions taken indicates that training has been effective in mitigating the incidence of cup loosening.

How long has the Durom Cup been on the market?

The Durom Cup was launched in Europe, Canada and Australia in 2003, India and Korea in 2005, and Argentina in 2006. In the U.S., the Durom Cup was launched in 2006.

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