Description of Event or Problem · 1
DURING BOTH OPERATIVE PROCEDURES, AT THE TIME OF BONE CEMENT IMPLANTATION, THE PATIENTS EXPERIENCE RESPIRATORY ARREST AND SUBSEQUENT CARDIAC ARREST REQUIRING RESUSCITATION. IN THE CASE OF THE PATIENT SHE WAS SUCCESSFULLY RESUSCITATED IN THE OR AND IN THE RECOVERY ROOM WHEN SHE AGAIN CODED, BUT THEN EXPIRED APPROXIMATELY THREE HOURS POST-OP WHILE STILL IN THE RECOVERY ROOM. IN THIS CASE, RESUSCITATION ATTEMPTS WERE UNCSUCCESSFUL AND THE PATIEN WAS PRONOUNCED DEAD IN THE OPERATING ROOM. AUTOPSY WAS NOT PERFORMED ON EITHER PATIENT. THE PRESUMED CAUSE OF DEATH IN EACH INSTANCE, WHICH WAS ENTERED ON THE DEATH CERTIFICTE, WAS PULMONARY EMBOLUS. BOTH PATIENTS WERE IMPLANTED WITH SMITH AND NEPHEW RICHARDS, INC. BIPOLAR HIP PROSSTHESIS AND AN INTRAMEDULARY CEMENT RESTRICTERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.