Zimmer Durom Cup Hip Implant Attorneys
Was the Zimmer Durom Cup Implant Recalled?
On July 24, 2008 Zimmer Holdings, the nation’s largest provider of orthopedic devices, announced that it was suspending the sales of a metal on metal artificial hip implant due to reports of high failure rates in U.S. patients. The implant device is an artificial hip socket known as the Zimmer Durom Cup. The Zimmer Durom Cup device was approved by the FDA in 2006 and has been implanted in approximately 12,000 U.S. patients.
Officially, the Zimmer Durom Cup was never recalled. Zimmer simply suspended the sale of the Durom Cup product in the U.S. market. The Durom Cup product has continued to be marketed outside of the U.S.
The Zimmer Durom Cup attorneys at Lutz, Bobo & Telfair, P.A. are reviewing potential Durom Cup lawsuits for those who have experienced problems after their hip replacement. To have a potential case reviewed by one of our product liability lawyers, request a no cost consultation and case evaluation. There are no fees or expenses unless a recovery is obtained.
Zimmer Durom Hip Implant Failures
The first problems for the Zimmer Durom Cup were reported in April 2008, by prominent Los Angeles orthopedic surgeon, Dr. Larry Dorr. Dr. Dorr notified members of the American Association of Hip and Knee Surgeons about the problems he was encountering with patients who received the Zimmer Durom Cup implant. Loosening of the components and a higher than expected rate of revisions were the problems identified by Dr. Dorr.
Initially Zimmer dismissed Dr. Dorr’s report of problems. Zimmer launched its own clinical investigation into the implant failure reports in May 2008. Zimmer’s clinical investigation included twelve hip implant sites, four in Europe and eight in the U.S. In addition, Zimmer reviewed the patient data for 1,300 Durom Cup recipients. Per Zimmer, “Of the sites investigated in the U.S. that employed appropriate and necessary surgical techniques, Zimmer found that the combined revision rate was 1.5%. Conversely, the revision rate for other sites was 5.7%.” Zimmer went on to say, “With appropriate training support to surgeons, we are confident of achieving patient outcomes in the U.S. that are consistent as what we have seen historically in Europe.”
The cause of the failures as well as the failure rate of the Zimmer Durom Cup has been highly contested between Zimmer and the surgeons who performed the implant surgery.
Zimmer has pointed to improper surgical technique. In Zimmer’s communication on July 22, 2008 they stated, “Within the next several weeks, Zimmer will issue a further communication to U.S. surgeons providing them with updated labeling, which will include the more detailed surgical technique instructions. The company is also developing a comprehensive surgical skills training curriculum, working with experts in Europe and the U.S. Following initiation of a new training program, the Durom Cup will be made available to surgeons as they complete training.”
Many surgeons feel the blame falls on Zimmer Holdings for marketing a new product without providing adequate warnings or instructions about the proper use and surgical techniques required.
Zimmer Durom Cup Injury Attorneys
Over 12,000 people in the U.S. had a Zimmer Durom Cup implanted during their hip replacement surgery. Many of these people have experience unexplained hip pain more than three months after the surgery, loosening of the component and the need for additional hip surgeries.
The Zimmer Durom Cup injury attorneys at Lutz, Bobo & Telfair, P.A. are reviewing potential Zimmer Durom Cup lawsuits for those who have experienced problems after their hip replacement surgery. To have a potential Zimmer Durom Cup case reviewed by one of our product liability lawyers, request a no cost consultation and case evaluation today. There are no fees or expenses for injury cases unless a recovery is obtained.
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