Description of Event or Problem · 1
A RIGHT TOTAL KNEE REPLSCEMENT WAS PERFORMED IN 2/88. IN 3/92, THE PATIENT EXPERIENCED DECREASED RIGHT KNEE RANGE OF MOTION AND INSTABILITY UPON WALKING. X-RAY REVEALED WEARING OF (R) KNEE PROSTHESIS AND PATELLA COMPONENT WAS FOUND TO BE FRACTURED AND WAS REPLACED W/O COMPLICATION ON 4/15/92. ADDITIONAL ORIGINAL DEVICES INVOLVED (2 OTHER COMPONENTS OF (R) TOTAL KNEE REPLACEMENT UNIT) WERE: HOWMEDIA FEMORAL AND TIBIAL COMPONENTS; THESE COMPONENTS REMAIN INTACT AND STABLE. THE DEVICE PURCHASE DATE IS UNKNOWNDEVICE NOT 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.