PCA SMALL DOME METAL BACKED PATELLA

Description of Event or Problem

PATIENT COMPLAINT OF A JOG EXPERIENCED IN RIGHT KNEE - MILDLY SWOLLEN. REVISED KNEE RIGHT - 1/20/93 (SOME LOSS OF METAL LEFT SPACE RIGHT KNEE - PER PHYSICIAN PRIOR TO REVISION SURGERY). PCA DOME PATELLA SHOWED POLYETHLINE WEARDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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.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.