Zimmer Durom Cups
Zimmer manufactures a number of surgical products, including orthopaedic reconstructive joint products. Between 2006 and 2008, around 12,000 people had a hip replacement procedure with a one-piece synthetic hip implant called the Zimmer Durom Acetabular Component, more commonly referred to as the Durom Cup.
The Zimmer Durom Cup is a metal hip implant component that, along with numerous metal-on-metal hip replacement devices, did not live up to the promises made by manufacturers.
Zimmer Holdings Inc. sent out a voluntary notice of recall in 2008 as news spread of serious complications. Unfortunately, for the approximately 12,000 patients who already had the device implanted, the recall came too late. Thousands of patients who had the defective medical device implanted were harmed, and many have now filed lawsuits against Zimmer.
If you or a loved one was among those who suffered harm as a result of the Durom Cup, you too may have a claim against the manufacturer. An experienced defective medical device attorney at Roberts & Roberts can review your claim and advise you about your potential right to compensation.
Zimmer Durom Cups and Hip Replacement Procedures
The Durom Cup consists of a one-piece metal socket device made of a cobalt-chromium alloy with a plasma coating.It fits inside of the acetabulum (the indentation in the pelvis), and its coating is designed to encourage the growth of the bone. The natural bone growth was supposed to keep the cup in place.
When used in conjunction with the Zimmer Metal-on-Metal Tribological Solution Large Diameter Head (LDH), the Durom Cup was promoted as a long-lasting solution.The LDH, with its larger diameter, also allowed for greater range of motion.
The Durom Cup, like most metal-on-metal hip replacement products, was heavily advertised to younger patients with more active lifestyles. Manufacturers indicated that the replacement hip joints made of all metal could last for as long as 15 to 20 years.
Also like other metal-on-metal devices, the Durom Cup was approved in 2006 by the FDA under special 510(k) rules that allowed for approval with limited testing because it was substantially similar to existing products on the market.
Complications with the Durom Cup
Although the Durom Cup was supposed to provide a longer-lasting and better hip replacement procedure, problems soon began to arise. The major issue was that the Durom cup was prone to slipping out of place, in large part because the coating intended to stimulate the growth of the bone didn’t always work.
Often, the cup failed to attach to the bones and would start to float around, causing patients to experience serious sharp pains in the lower back or hips. Many patients who had the Durom Cup implanted also started to experience limited mobility as a result of the bad replacement joint.
Symptoms of complications include:
- Severe stiffness and pain, especially when rising from a seated position
- Noticeable limping, especially when rising from a seated position
- Sharp groin pain when standing upright from a bent or seated position
- Pain when walking down stairs or an inability to walk down stairs
- Limited mobility, lack of endurance and a need for assistive devices such as a cane or walker when walking.
When problems developed, generally the only solution was a revision surgery. This could be expensive and painful, and extracting the cup often required extensive reconstruction.
Just one year after the release of the product, a hip surgeon reported the following results from the 165 hip implants he had done using the Durom Cup:
- 10 hip replacements had already failed and revision surgery was required.
- Another four hips would need revision surgery soon.
- The Durom Cup was likely to fail within two years of the initial hip replacement procedure.
- The Durom cup lacked adequate fixation and could migrate.
The FDA published news of the surgeon’s findings in its MedSun Newsletter in March 2009.
Zimmer discovered that when doctors used what they believed to be proper surgical techniques, revision surgeries were required due to failure in only 1.5 percent of cases. However, when what they called “improper” surgical techniques were used, revision surgery was required due to failure in as many as 5.7 percent of cases.
In response to the problems, Zimmer sent out a voluntary notice in 2008, indicating that it was “temporarily suspending marketing and distribution of the Durom® Acetabular Component (Durom Cup) in the United States, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S.“
A 2010 survey in the Journal of Arthroplasty reported an 11 percent failure rate for patients who had the Durom Cup implanted.
Compensation for Injuries from Zimmer Durom Cups
Patients who experienced complications and who required revision surgeries have already begun to file lawsuits against Zimmer to obtain compensation.Some cases have settled already, but many more remain.
If you or a loved one suffered harm as a result of a Zimmer Durom Cup, you may be entitled to compensation.
The defective medical device attorneys at Roberts & Roberts are currently investigating claims related to hip implants and hip replacements. For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.
- U.S. National Library of Medicine – “Failure of the Durom Metasul® Acetabular Component”
- MedSun — Newsletter #34, March 2009
- Journal of Arthroplasty – “Large Head Metal-on-Metal Total Hip Arthroplasty Using the Durom Acetabular Component at Minimum 1 Year Interval”
- Zimmer – Background on Durom® Cup Status
- Zimmer – Durom Surgeon Letter