KINEMATIC II ROTATING HINGE KNEE

Description of Event or Problem

PT HAD A 20+ YEAR SEVERE CHEMICAL EXPOSURE. RESULTED IN TOXIC SYNOVITIS, TOXIC ARTHRITIS. HAD TOTAL KNEE REPLACEMENT SEVERAL VEARS AGO. THIS FAILED. IT WAS REPLACED 1/31/91 WITH A KINGEMATIC II TOTAL KNEE. ON 4-23-92 THIS PATIENT RETURNED TO SURGERY FOR REPLACEMENT OF KINGEMATIC II TOTAL KNEE. THE TIBIAL PART WAS BROKEN. THE TIBIAL PARTS ONLY WERE REPLACED. THE FEMORAL PART FROM SURGERY ON 1/31/91 WERE LEFT IN PATIENT.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.