KINEMATIC KNEE

Description of Event or Problem

AT SURGERY THERE WERE THREE PIECES OF POLYETHYLENE LOOSE IN THE JOINT SPACE. THE INSERT WAS DELAMINATING AND FRACTURED. SYNOVECTOMY WAS PERFORMED AND CUTTING REVEALED A LARGE CYST UNDER THE MEDIAL ASPECT OF THE TIBIAL TRAY. CYST WAS REMOVED, TRAY REMAINED STABLE SO CEMENT WAS USED TO FILL THE VOID AND A REPLACEMENT INSERT WAS INSERTED.DEVICE 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: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.