LG LT PCA STEMMED BEADED TIBIAL COMPONENT & LG PCA BEADED..

Description of Event or Problem

SURGEON REPORTS THAT DUE TO EVENTS BELOW, THE PATELLA COMPONENT SHOWED EXTENSION BREAKAGE AND WEAAR OF THE "POLY" ONLY, WITH NO "METAL-ON-METAL" WEAR ON THE FEMOR. THE 7MM "POLY" WERE REMOVED AND REPLACED WITH AN ALL PLASTIC PATELLA AND A NEW MECHANICAL 7MM "POLY" INSERT.APPROX. TWO ONTHS PRIOR TO EXPLANT SURGERY, PATIENT WAS ENTERING PASSENGER SIDE OF FAMILY CAR WHILE VEHICLE WAS BACKING UP. THE VEHICLE IMPACTED PATIENT'S LEFT KNEE WHILE FLEXED. PATIENT EXPERIENCED KNEE CREPITATION IMMEDIATELY AFTERWARDS WITH KNEE PAIN THAT INCREASED DAILY UNTIL EXPLANT SURGERY WAS PERFORMED. SURGEON FEELS THT THE PATELLA CRACKED ON IMPACT AND THE DEBRI CAUSED, OR ADDED, IN THE MINOR DELAMINATION OF THE TIBIAL "POLY"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.INVALID DATA - REGARDING EVALUATION BY USER AFTER 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: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.