Description of Event or Problem · 1
PATIENT HAD ORIGINAL TOTAL JOINT REVISION DONE ON JANUARY 15, 1986. SHE HAD A LONG HISTORY OF PAIN AND SWELLING IN THAT JOINT. SHE HAS BEEN FOLLOWED IN THE PHYSICIAN'S OFFICE WITH VISITS AND X-RAYS. FOUR MONTHS AGO, X-RAYS REVEALED INCREASED RADIOLUCENCY AROUND ALL COMPONENTS INDICATIVE OF EARLY OR COMPLETE WEAR OF COMPONENTS. PATIENT AND SURGEON ELECTED FOR REVISION OF TOTAL JOINT ON JUNE 23, 1993. PLASTIC COMPONENTS SHOW SIGNS OF WEAR AND DETERIORATIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, END OF LIFE - PREMATURE, MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.