Modern medicine has made some amazing improvements in medical devices that change the quality of life for many people. One such improvement is the hip implant. However sometimes these pioneering new techniques haven’t been tested enough such in the case of the failure of the Zimmer Durom Cup hip replacement.
Many of the patients implanted with the Zimmer Durom Cup have reported experiencing pain and discomfort long after the surgery. Many of the patients reported these symptoms to their doctors who typically reviewed X-rays to determine the implants were properly positioned. The doctors were often unable to explain their clients’ persistent symptoms when the post surgical X-rays confirmed proper placement of the implants. It was eventually determined that defects in the replacement implants themselves were the cause of the persistent symptoms in many cases.
The initial response of the manufacturer was to insist surgical errors were the cause of the persistent symptoms in many cases. Three leading orthopedic surgeons, including one retained by the manufacturer to support its surgical error theory, came forward to refute the company’s argument
At the annual meeting of the American Academy of Orthopedic Surgeons this past February, Dr. Lawrence Dorr and three of his colleagues Dr. Zhinian Wan, Dr. William Long and Dr. Manish Dastane presented a poster on patient outcomes involving the Zimmer Durom cup. In the poster abstract, the group reports:
The Durom cup failed fixation leading to a radiographic failure rate of aseptic loosening of 1 in 4 cups and clinical failure in 2 of 10 patients. The cause of failure is the cup geometry and sharp peripheral fins which result in peripheral fixation without contact of fixation surface to acetabular bone in some hips. Because we cannot predict in which patients this will occur we no longer use the Durom cup.
According to Dorr and his colleagues’ findings, approximately 25% of Durom patients had experienced loosening of their Durom cup by the time of this presentation, while at least 20% had to undergo a revision surgery to revise their failed Durom implant.
The theory posited by these renowned surgeons is that there is a problem with the design of the cup, itself, rather than a matter of mere surgical technique, as Zimmer has implied. In July 2008, Zimmer announced that it was temporarily suspending sales of the Durom Cup in the United States. Zimmer denies any “evidence of a defect” with the Durom Cup and has thus far refused to issue a recall notice in accordance with procedures established by the Food and Drug Administration.
The Zimmer Durom Cup Product Liability Litigation, which is pending in the US District Court in Newark, New Jersey, the Court ordered (December 2010) all cases to proceed to mediation. Zimmer said they are anxious to settle for a “fair amount,” which will include lost wages and medical bills and revision (or replacement) surgery as a result of failed Zimmer hip.
CA