MILLER GALANTE

Description of Event or Problem

IN 1987 (EXACT DATE UNKNOWN) THIS PATIENT HAD A MILLER-GALANTE TOTAL KNEE PERFORMED AT SPARKS HOSPITAL IN RENO, NEVADA. "SINCE THEN HE HAS REPEATED EPISODES OF RECURRENT SWELLING IN HIS RIGHT KNEE AND A FAIR AMOUNT OF PAIN. THE PATIENT IS HAVING QUITE A BIT OF DIFFICULTY WALKING AND ALSO IN TRYING TO GET UP FROM A SITTING POSITION." ON 3/5/92 THIS PATIENT WAS ADMITTED TO OROVILLE HOSPITAL FOR "REVISION OF RIGHT TOTAL JOINT ARTHROPLASTY".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. 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.