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Hip Implants - Zimmer Durom Cup Recall
Nearly 450,000 new total hip replacement surgeries are performed each year in the United States on patients with severe hip degeneration due to arthritis or trauma. The number of hip replacement surgeries performed is expected to skyrocket 174% in the next 20 years according to the American Academy of Orthopaedic Surgeonsdue to the aging baby boom generation.
Hip replacement surgery involves removing the ball and socket of the hip joint, and hip implants come in many shapes and sizes and are made from many different materials. Approved for market in March of 2006, the Zimmer Durom Acetabular Component (also called the Durom Cup) is a metal hip socket and has been implanted in an estimated 12,000 patients. The metal-on-metal hip implant is unique from traditional hip implants made of ceramic or plastic in that the Durom Cup is a solid metal cup made from cobalt chromium alloy and is sprayed with a titanium plasma-sprayed coating used for fixation to the bone. The metal-on-metal design helps to prevent the problem of wear and tear common with traditional hip implants. The cup device is designed to be used in combination with the Zimmer Metasul LDH Large Diameter Head. Zimmer Holdings, Inc., an Indiana-based company, is the nation's biggest producer of medical devices.
Zimmer Durom Cup Problems Emerge
Problems with the Durom Cup surfaced in April of 2008 when Dr. Lawrence Dorr, a nationally-known orthopedic surgeon in Los Angeles, publicly warned his colleagues within the American Association of Hip and Knee Surgeons about a large number of his patients experiencing a failure of the Durom Cup. Interestingly, Dr. Dorr was formerly a highly paid consultant for Zimmer. Dr. Dorr received similar feedback from other orthopedic surgeons whose patients had to undergo painful revision hip replacement surgeries due to a loosening of the Durom cup from the bone. Because the Durom Cup was easily removable during revision surgeries, it is likely that the hip bone was unable to incorporate the implant due to manufacturing defects in the cup's design and/or surface coating. Doctors suggest that hundreds of patients who were implanted with the Durom Cup may need revision hip surgeries in the coming years.
On July 22, 2008, under mounting FDA pressure, Zimmer temporarily suspended its marketing and distribution of the Durom Cup and sent a letter to U.S. orthopedic surgeons advising them to stop using the implant. In August of 2008, in what appeared to be an effort to shift blame to the surgeons rather than a design or manufacture defect, Zimmer attempted to blame surgical error for the problems associated with the implant and claimed that the company would update product labeling, revise surgical technical instructions, and offer a comprehensive surgical training program.
Tampa Metal Hip Implant Attorneys
If you or a loved one have been implanted with a Durom Cup hip implant device and have experienced pain more than three months following surgery, please contact the Tampa metal hip implant attorneys with the law firm of Alley, Clark & Greiwe for important information regarding your legal rights.
Helpful Consumer Information on Zimmer Durom Cup Claims:
- Click here to view the July 22, 2008, voluntary recall notice from Zimmer
- Click here to view the July 22, 2008, letter to U.S. orthopedic surgeons from Zimmer
- Click here to read a July 24, 2008, article from the New York Times about Durom Cup complaints
- Click here to read a July 29, 2008, article in the New York Times about the increased need for a national joint registry system on artificial joint products
- Click here to view the July 31, 2008, press release from Zimmer
- Click here to view an August 16, 2008, update from Zimmer to U.S. surgeons