PCA PRIMARY BASEPLATE
Received Mar 22, 1994 · Event occurred Feb 21, 1994
Report 33462-1994-01119 · MDR key 8652
Device
Patient
77 YR
Narrative
Description of Event or Problem
1) REVISE PREVIOUS REVISION OF PATELLA WITH A PATELLA FROM AN UNKNOWN MFG.2) TIBIA BASEPLATE WAS REMOVED DUE TO POLYETHELYNE WEAAAAR & DILAMINATION.DEVICE 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.