DOME PATELLA, SM & MED. LEFT TIBIAL INSERT

Description of Event or Problem

REV. KNEE SURGERY-PATELLA REMOVED-RECUT-CEMENTED IN NEW PATELLA. PLASTIC ON TIBIA WORN-REMOVED-TRAILED-REINSERTED WITH NEW PLASTIC TIBIA. PHYSICIAN FELET PATELLA HAD WORN THROUGH. IT HAD PLASTIC ON TIBIA COMPONENT. SHOWED SOME WEAR SO IT WAS REPAIRED AT THE SAME TIMEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.