This device, wholly embraced by the medical community when it first came onto the market, has proven to be a frustration not only for hip replacement patients, but also for the surgeons entrusted with their procedures.
A number of lawsuits are being investigated on behalf of patients who may have received these non-performing artificial hips, and who may have suffered pain and loss of income as a result. As well, surgeons who may have seen their reputations sullied by implanting the Durom Cup device without being made aware of the unique issues inherent with the Durom Cup installations may also consider lawsuits for compensation and damages.
At issue is the Durom Acetabular Component hip replacement device, manufactured by Zimmer and known throughout the industry as the Durom Cup. When it was approved by the US Food and Drug Administration (FDA) and introduced to the American market in 2006, it was initially viewed as a marked improvement to existing technology, in that the Durom Cup is fashioned from a single piece of wrought-forged, high carbon CoCr Metasul alloy. Among other advantages, according to Zimmer Holdings, the Durom Cup manufacturer, a hip replacement using the Durom Cup provides for less bone loss than traditional methods.
The Durom Cup was initially embraced by patients and surgeons alike. Upwards of 12,000 US hip replacement patients were provided with the new Durom Cup technology.
However, reports began to surface: problems with Durom Cups after implantation were unlike that of previous, more traditional medical devices. Patients were experiencing intense pain, and there were reports of significant failures quite soon after surgery. Many patients have been seriously inconvenienced.
Zimmer was reporting a failure rate of 5.7 percent, and of the 12,000 hip replacements done, the expectation was emerging that nearly 700 of those patients could expect to face additional surgery to repair, or ultimately replace the Durom Cup.
This finding was echoed in the contents of an open letter written to members of the American Association of Hip and Knee Surgeons and penned by noted surgeon Dr. Larry Dorr. He reported that out of 165 Durom procedures he had performed, 14 were "revised or required revision" within the first two years following initial surgery. That translates to a failure rate of 23 percent, as compared with Zimmer's own findings of a 5.7 percent failure rate.
Dr. Dorr used his findings to back up his assertion that the Durom Cup was defective. In his view 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.
It would explain the degree of pain and discomfort experienced by a growing number of Durom patients. Zimmer's response to Dr. Dorr's assertions was to announce an investigation into Durom Cup complaints, in May 2008. Two months later Zimmer voluntarily ceased all marketing and sales of the Durom Cup, pending the launch of a training program to educate surgeons on the proper technique required for installing a Durom Cup.
The assertion that the Durom Cup requires specialized training over, and above what even the most skilled orthopedic surgeons would be capable, raises the question as to why the device was not more thoroughly field tested prior to the issuance of FDA approval.
Dr. Dorr was of the opinion, in April 2008 that the Durom Cup was defective. However the manufacturer did not share his view. Therefore, there was no Durom Cup recall. The manufacturer, Zimmer Holdings, holds the position that their device is not defective, and therefore concludes that the problem lay with improper implantation based on the uniqueness of the Durom Cup.
The manufacturer should have required additional training in order to facilitate the successful installation of a Durom Cup hip replacement, and should have communicated this need with surgeons
Zimmer Holdings announced additional labeling to the medical device 4 months later, and the launch of an Internet-based training program geared towards surgeons. It is obvious that had these device label changes and training requirements been introduced in 2006 prior to FDA approval of the Durom Cup, hundreds of patients and their surgeons would not have been negatively impacted.
If you have undergone hip replacement surgery within the last two years and are now experiencing difficulty, you may have received a Durom Cup from Zimmer Holdings. Zimmer Holdings has set aside $47.5 million to fund claims. Our firm can help you investigate the potential for compensation for your suffering.
