ROBERT BRIGHAM UNI-CONDYLAR KNEE - REINFORCED TIBIAL PLATEAU

Description of Event or Problem

THE UNI-CONDYLAR KNEE COMPONENTS WERE NOTED TO BE SIGNIFICANTLY DAMAGED WITH THE POLYETHYENE QUITE FRAGMENTED AND THE BASEPLATE OF THE TIBIAL COMPONENT EXPOSED UPON EXPLANTATION. THERE WAS WEAR ON THE FEMORAL COMPONENT. PIECES OF POLYETHYLENE WAS FOUND THROUGHOUT THE JOINT.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. INVALID DATA - WHETHER 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.