Revision Surgery Rises at One Hospital Due to Defective DePuy Metal-on-Metal Hip ImplantMar 22, 2013
Revision surgery on patients implanted with DePuy Orthopaedic’s metal-on-metal ASR hip replacement system continues to rise each year, based on a close look at one medical facility, Carle Foundation Hospital in Champaign, Illinois, MedPage Today reported.
As for the rate of revision surgery caused by the implant, after three years of follow up, 69 such surgeries were performed on patients who had received the hip implant between 2006 and 2009, Chris J. Dangles, M.D. of Carle Foundation Hospital in Champaign, Ill., told MedPage Today.
At the four-year mark, revision surgeries climbed to 82. Nearly half the women who had received the implant required revision surgery. Also, after four years, the general period before revision surgery was required ranged from 100 to 2,123 days.
The DePuy ASR Acetabular Cup System first came on the market in 2005, having achieved approval by the U.S. Food & Drug Administration (FDA).
Thousands of people in the U.S. were implanted with DePuy's ASR system between 2005 and 2010, when the device was recalled. Many patients experienced the premature failure of the hip implant within a few years of surgery, and those who haven’t experienced problems yet may in the future, necessitating follow-up surgery for them as well.
One year before the recall DePuy announced it would be phasing out the ASR hip implant, supposedly due to low sales. At the same time, the FDA, as early as 2008, had received more than 300 reports of problems with the hip implant, most of which involved premature failure that required revision surgery.
While a typical hip implant should last for about 15 years, many DePuy ASR hip implant recipients were undergoing revision surgeries only a few years after implantation.
The DePuy ASR hip implant can fail in numerous ways, including: loosening of the implant’s various components; necrosis (premature death of body tissue) or soft tissue damage due to exposure to the release of metal particles from the wear of the implant; elevated cobalt and chromium levels in the blood, also due to wear of the implant.
Among the symptoms suffered by patients implanted with the device include severe pain around the implant that radiates into the groin and/or back; radiographic changes, including osteolysis; and fluid collections and cystic or solid masses around the joint.
Carle Foundation Hospital stopped using the implant 18 months before the recall, “after we had five unusual revisions, including cases of motion of the acetabular cup, and adverse reactions in local tissue, including pseudotumors, fluid in the capsule, and tissue staining,” Dangles told MedPage Today.
Once the implant was formally pulled off the market, the hospital contacted the patients who’d had the ASR hip implant procedure, informed them of the recall, and admitted them to the clinic for physical examinations that included imaging and blood work – the latter to measure the presence of elevated cobalt and chromium levels in the blood caused by the wear of the metal.
In reviewing its overall experience with this particular metal-on-metal hip implant, Carle Foundation Hospital noted that 359 hips had been implanted in 314 patients. Recipients' average age was 65, and more than 200 were men. Osteoarthritis was the most common reason for a patient obtaining the implant in the first place.
Nineteen of these implant patients have died; seven had undergone a revision procedure.