What went wrong with the Zimmer “Durom Cup”?
Zimmer Holdings:
Zimmer Holdings designs, develops, manufactures, and markets reconstructive orthopedic implants, including joint, dental and spinal implants, trauma products, and related orthopedic surgical products.
Zimmer Durom Acetabular Component aka “Durom Cup” Explained:
The Durom Cup is a newer type of artificial hip part, which is designed for use in combination with Zimmer’s Matasul Metal-on-Metal Tribological Solution Large Diameter Heads. The hip replacement cup is a monoblock of cobal chromium alloy, which was introduced in Europe in 2003 and approved in the US in 2006.
Unlike traditional hip replacement parts, the Zimmer Durom Cup is made from a single piece of material and is designed to address some of the more common problems with hip replacement components, such as wear of the bearing, limited range of motion, and instability.
Physicians Discovery of Problems with the Durom Cup:
In early 2008, Dr. Lawrence Dorr reported his concerns about the Durom Cup to executives at Zimmer. Zimmer failed to take action with regard to Dr. Dorr’s warnings. In April of 2008, Dr. Dorr publicly warned other orthopedists about cup failures his patients were experiencing. In late May, Zimmer finally informed surgeons that it was investigating Dr. Dorr’s complaint but it did not suspend sales as the doctor recommended. While it investigated complaints, roughly 1,300 more patients were implanted with the Durom Cup in the US.
Problems Discovered:
Dr. Lawrence Dorr, a once highly paid consultant for Zimmer and veteran of more than 5,000 hip replacement surgeries, states that the socket was separating from the bone rather than fusing with it. The fixation surface on the cup was problematic, and a circular cutting surface on the periphery of the cup prevented the device from fully seating.
Injuries Associated with the Durom Cup:
Physicians who have done further surgery to determine the cause of patient discomfort have found that the cups have loosened over time to the point where they just pop from the sockets at the slightest touch. Other patients have devices which have actually migrated a short distance in their bodies so they are no longer located exactly where they should be.
Patients mostly suffer the effects of their implant slipping, loosing of the implanted joint, and infection. Generally, a second surgery is necessary to append the first.
FDA Approval:
When a new procedure is designed, or radically new device is fashioned, rigorous field-testing is required before the device can be approved for use in the wider market. When a new medical device is introduced to address an existing procedure, only a cursory approval is usually required by the FDA.
Thus, procedure improvements with new devices can usually be brought to market much more rapidly, allowing the manufacturer to realize a return on investment much more quickly. Given that the Durom Cup is not a new device addressing a new procedure, only a cursory approval by the FDA was required.
Statistics:
So far, 12,000 patients have had Zimmer Durom Cups installed as their replacement hips since they were approved for use in the US in 2006.
Zimmer was reporting a failure rate of 5.7%, with the expectation that 684 patients will likely need, or have already suffered through a second surgery to append the first.
Dr. Lawrence Dorr reported that out of 165 Durom procedures he preformed, 14 were “revised or required revision” within the first 2 years following initial surgery. That translates to a failure rate of 23%, as compared with Zimmer’s own findings of a 5.7% failure rate
Zimmer’s Position:
Zimmer communicated to healthcare providers in May of 2008 that there were reports of problems, and that it was investigating. Following a review of 3,100 cases, Zimmer made the decision to suspend sales of the Durom Cup pending an update to the product labeling, and the implementation of a new surgical training program in the US to train surgeons on the proper way to install the devices.
Zimmer asserts that the Durom Cup is such a unique animal that it requires specialized training that would be over and above what even most skilled orthopedic surgeons would be capable.
Zimmer refuses to recall the Durom Cup. It holds the position that in spite of failures, there was no manufacturing, or design defect inherent with the components. Zimmer concludes that the problem lay with improper implantation based on the uniqueness of the Durom Cup.
Zimmer announced in October of 2008 that it had set aside $47.5 million to cover claims, and revisions required for surgeries which occurred prior to the company suspending sales in July of 2008.
Zimmer has announced additional labeling to the medical device, and the launch of an internet-based training program geared towards surgeons. It has been reported that doctors are required to successfully complete the Durom Cup training program online, before Durom Cups will again be made available to them. As of November 1, 2008, it was reported that about half of the surgeons who had been using the Zimmer Durom Cup prior to the suspension of sales in July of 2008, had accessed the training for the Zimmer hip prosthesis.
If you or a loved one is suffering from Durom Cup Implant, please call the Garrett Law Office – 1-888-427-7388
List of articles in which the above information was obtained:
Zimmer Hip Replacement Patients Caught in the Middle by Gordon Gibb on 11/17/08. Last visited 3/09 www.lawyersandsettlements.com/articles.html?case=zimmer-hip-replacements.
The Zimmer Durom Debacle by Gordon Gibb on 12/6/08. Last visited 3/09 www.lawyersandsettlements.com/articles.html?case=zimmer-hip-replacements.
The Bumpy Road of the Zimmer Durom Cup Hip Implant by Maxwell Schmickman. Last visited 3/09 http://justwantinfo.com/articles/legal/the-bumpy-raod-of-the-zimmer-durom-cup-hip-implant.html
Lawsuits are Pending against the Zimmer Durom Cup on 2/19/09. Last visited 3/09 www.zimbio.com/Zimmer-Cup-Recall/articles/23/Lawsuits+Pending+against+Zimmer+Durom+Cup
Zimmer Durom Cup Hip Implant Injury Lawyers failed to get information.