D
Patient 1
PATIENT EXPERIENCE PAINFUL TOTAL KNEE WITH POLYMER. REVISION PERFORMED JANUARY 23, 1992. ON PATHOLOGICAL EXAMINATION, THE METALLIC FEMORAL COMPONENT MEASURED 5.3 X 4.6 CM. THE METALLIC ARTICULAR SURFACE WAS SMOOTH AND SHINY. THE HIGH DENSITY POLYETHYLENE AND METALLIC PATELLAR COMPONENT MEASURED 3.5 X 3.0 X 1.0 CM. THE ARTICULAR SURFACE WAS FOCALLY ROUGHENED. THE HIGH DENSITY POLYETHELENE AND METALLIC TOTAL COMPONENT MEASURED 5.8 X 4.0 X2.0 CM. THE ARTICULAR SURFACE WAS MARKEDLY WORN. THE PATHOLOGICAL DIAGNOSIS WAS CHRONIC PROLIFERATIVE SYNOVITIS WITH FOREIGN BODY REACTIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION, OTHER. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.