Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer claims to be a worldwide leader in designing, developing, manufacturing and marketing orthopaedic reconstructive trauma devices, including total hip replacements. Total hip arthroplasty (THA), or total hip replacement, is a medical procedure performed on more than 442,000 patients in the U.S. each year. Zimmer owns a quarter of the total hip market, making it the world leader.
In the U.S., Zimmer's Durom Cup (also known as the "Durom Acetabular Component" or "Metasul Durom") was cleared for marketing in THA by the FDA in mid-2006. The Durom Cup has been implanted in approximately 13,000 patients since it was first sold in the United States. The Durom Cup was designed for use in younger patients who are likely to outlive a conventional hip prosthesis. However, the results for many patients has been just the opposite, as the metal component of the hip implant fails to bond properly with the existing bone. Instead, the metal socket loosens and separates, resulting in severe pain and ultimately device failure, necessitating an expensive and painful revision surgery for patients.
The problems with the Durom Cup first came to light in 2007 when prominent orthopedic surgeon Dr. Lawrence Dorr, the Director of the Dorr Institute for Arthritis Research and Education, alerted Zimmer that Durom Hip Implant had an abnormally high failure rate. The company did nothing, forcing Dr. Dorr to take the issue public.
In April of 2008, Dr. Lawrence Dorr publicly warned other orthopedists about failures with the Zimmer Durom Cup his patients had experienced. His letter to fellow doctors reads in relevant part,
This NOTICE is to inform you that we have had ten revisions in 165 hips and have four more that need to be revised using the Durom cup.
This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions.
We have notified Zimmer. The FDA has been notified and we will notify them of our continued revisions. 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. I went through a similar scenario with the Sulzer cup failures where I was the only one experiencing revisions at the beginning and basically it was assumed that it was our technique. I can assure you that this goes beyond technique. I learned my lesson in not informing everyone about this magnitude of failures with the Sulzer cup problem, so it is my obligation to do so with this cup.
In May of 2008, Zimmer finally announced it would begin an investigation, but made no indication it would recall the device or halt sales. Then on July 24th, 2008, Zimmer suspended the marketing and distribution of the Durom Cup in the United States. [READ the Notice here] It didn't suspend marketing outside the U.S., where lower revision rates had been reported. Zimmer declared their investigation had revealed that the Durom Cup was not defective. Rather, the company blamed the doctors. It stated that surgeons had found the device difficult to implant, and that it was the responsibility of doctors to receive more training on how to implant the device. Zimmer then updated the device label and implemented a surgical-training program in the U.S.
Since that time, hundreds of patients have suffered device complications and failures due to the Zimmer Durom Hip Cup. If you or a loved one had a Zimmer Hip Replacement between 2006 and 2008 and believe it might have been a Durom Cup, please contact us immediately to protect your rights.