Description of Event or Problem · 1
ON THE MORNING OF 6/3/98, THE CO REC'D A PHONE CALL FROM THE SALES AGENT, REGARDING AN INCIDENT INVOLVING COMPONENTS OF THE CONSENSUS BIPOLAR HIP SYSTEM. THE COMPONENTS IN QUESTION HAD BEEN IMPLANTED IN 1998. THE PT WAS A 70 YEAR OLD FEMALE. THE IMPLANTED COMPONENTS WERE AS FOLLOWS: CAT. NO.: 1010-1-0008, LOT NO.: 170260, DESCRIPTION: FEMORAL STEM, COLLARED, NONPOROUS COCR, SIZE 8, CAT. NO.: 0007-0-2801, LOT NO.: 170396A, DESCRIPTION: FEMORAL HEAD, 28MM, -5MM, CAT. NO.: 1014-0-0045, LOT NO.: 420096, DESCRIPTION: BIPOLAR HEAD, COCR, 45MM, AND CAT. NO.: 1015-0-4547, LOT NO.: 180545, DESCRIPTION: BIPOLAR INSERT, UHMWPE, 45/46/47MM. SEVERAL DAYS POST-OPERATIVELY, THE ENTIRE IMPLANT ASSEMBLY DISLOCATED FROM THE PT'S ACETABULUM AND UPON X-RAY IT WAS FOUND THAT THE 28MM FEMORAL HEAD HAD DISASSOCIATED FROM THE BIPOLAR HEAD ASSEMBLY. REVISION SURGERY WAS SCHEDULED FOR 6/3/98 TO REMEDY THE PROBLEM. UPON EXAMINATION OF THE RETRIEVED PRODUCT, THE FOLLOWING COMMENTS WERE MADE: 1) DR NOTED HAVING SOME DIFFICULTY WITH THE ORIGINAL ASSEMBLY OF THE BIPOLAR HEAD/INSERT. THIS MAY HAVE RESULTED IN THE DEFORMATION OF THE LOCKING RING. 2) DR NOTED THAT THE INSERT APPEARED TO SNAP INTO PLACE IN THE HEAD. 3) THE 28MM FEMORAL HEAD WAS SEATED FIRMLY ON THE MORRIS TAPER OF THE FEMORAL STEM. 4) THE 28MM FEMORAL HEAD WAS FOUND OUTSIDE THE BIPOLAR INSERT. 5) THE BIPOLAR INSERT APPEARED TO BE THREE OR FOUR CENTIMETERS AROUND IN THE BIPOLAR HEAD UPON VISUAL INSPECTION. THE FEMORAL HEAD, BIPOLAR INSERT AND BIPOLAR HEAD WERE RETRIEVED FROM THE PT AND REPLACED WITH THE FOLLOWING COMPONENTS: CAT. NO.: 0007-0-2801, LOT NO.: 170149B, DESCRIPTION: FEMORAL HEAD, 28MM, NEUTRAL, CAT. NO.: 1014-0-0045, LOT NO.: 420096, DESCRIPTION: BIPOLAR HEAD, COCR, 45MM, AND CAT. NO.: 1015-0-4547, LOT NO.: 180545, DESCRIPTION: BIPOLAR INSERT, UHMWPE, 45/46/47MM. THE PARTS ARE TO BE RETURNED (RGA # 1037) FOR ENGINEERING FAILURE ANALYSIS. THE PARTS SHALL BE DECONTAMINATED PRIOR TO FURTHER PROCESSING. THIS IS DEEMED AN MDR-REPORTABLE INCIDENT (MDREVAL).