ROBERT BRIGHAM UNI-CONDYLAR KNEE - REINFORCED TIBIAL PLATEAU

Description of Event or Problem

PT. EXPERIENCED SWELLING OF HIS RIGHT KNEE IN SEPT, 1993. X-RAYS WERE TAKEN WHICH REVEALED A "FATIGUE CRACK" IN THE PROSTHETIC COMPONENT. REVISION RIGHT TOTAL KNEE ARTHROPLASTY WAS DONE ON 1/7/94. (THE ANTERIOR FEMORAL RUNNER HAD COMPLETELY FRACTURED AND WAS LOOSE).DEVICE 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. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.