Description of Event or Problem · 1
PATIENT WAS ORIGINALLY TREATED FOR COLLASPED FEMORAL HEAD WITH CEMENTLESS LEFT HIP REPLACEMENT IN MAY 1991. ON 3/26/93 PATIENT HAD REVISION OF LEFT TOTAL HIP ARTHROPLASTY (FEMORAL AND ACETABULAR COMPONENTS) DUE TO PAINFUL, FAILED LEFT HIP REPLACEMENT. CATALOG NUMBER TAG FOR KIRSCHNER BIPOLAR HEAD PLACED IN MEDICAL ARECORD DOES NOT MATCH CATALOG NUMBER ON DEVICE ITSELF. PATIENT WAS FOUND TO HAVE METAL DEBRIS IN HIP JOINT., CAUSED BY THE INNER HEAD OF THE BIPOLAR COMPONENT WEARING THROUGH THE POLYETHYLENE LINER AND COMING IN CONTACT CWITH THE OUTER METAL HEAD. DEVICE MAY BE SENT TO KIRSCHNER FOR EVALUATIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. 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.