Description of Event or Problem · 1
THIS MESSAGE ALERTS ONE TO WIDE PRESS COVERAGE EXPECTED ON THURSDAY 19 FEBRUARY 1998 FOLLOWING DISTRIBUTION BY THE MED DEVICES AGENCY (MDA) OF A HAZARD NOTICE CONCERNING THE CAPITAL HIP REPLACEMENT MFG BY 3M HEALTH CARE LTD. MDA IS INVESTIGATING REPORTS THAT THE CLINICAL PERFORMANCE OF THIS DEVICE FALLS SHORT OF THE ACCEPTED HIGH STANDARDS OF HIP REPLACEMENTS. SEVERAL HOSPS HAVE REPORTED IMPLANT FAILURE IN UP TO 21% OF CASES BY 5 YRS. THIS IMPLANT WAS AVAILABLE BETWEEN 1991 AND 1997 AND IT IS ESTIMATED THAT IT WAS USED IN 4700 PTS IN THE UK. THIS REPRESENTS LESS THAN 2% OF ALL HIP REPLACEMENTS PERFORMED OVER THAT PERIOD. THE FEMORAL COMPONENT APPEARS TO BE LOOSENING EARLY AND THERE MAY BE EXTENSIVE BONE LOSS IN THE PROXIMAL FEMUR. EARLY ID OF THESE FEATURES IS IMPORTANT SO THAT REVISION SURGERY CAN BE PERFORMED IN APPROPRIATE CASES. ALTHOUGH SOME PTS MAY HAVE ALREADY PRESENTED WITH SYMPTOMS, THERE IS A GROUP OF ASYMPTOMATIC PTS. THE ADVICE MDA HAS GIVEN TO HOSP IS THAT THEY SHOULD IDENTIFY ALL PTS WHO REC'D THIS IMPLANT AND RECALL THEM FOR CLINICAL AND RADIOLOGICAL EXAMINATION AND LONG TERM FOLLOW UP. PTS WHO HAVE UNDERGONE A HIP REPLACEMENT ARE UNLIKELY TO KNOW WHICH TYPE OF IMPLANT THEY HAVE REC'D. IF THEY DO NOT HEAR FROM THE HOSP WHICH CARRIED OUT THEIR ORIGINAL OPERATION, THEY MAY BE REASSURED THEY HAVE NO CAUSE FOR CONCERN. WHEN PTS HAVE MOVED AWAY FROM THE LOCALITY WHERE THEY REC'D THEIR IMPLANT, THE HOSP WHICH CARRIED OUT THEIR OPERATION SHOULD BE CONTACTED.