PCA KNEE
Received May 18, 1993 · Event occurred Mar 31, 1993
Report 33446-1993-09007 · MDR key 5432
Device
Generic name
Total Knee
Manufacturer
Howmedica, Inc.Catalog number
6638-1-950 & 6638-3-609
Lot number
MHGORA & MEDSAB
Patient
66 YR
Narrative
Description of Event or Problem
PATELLA GROSSLY LOOSE, WAS REMOVED BY HAND. VERY LITTLE INGROWTH EXHIBITED, MAINLY FIBROUS TISSUE. TIBIAL COMPONENT WAS REMOVED, REVEALING LARGE CYSTS AROUND FIXATION PEGS AND POSTERIOLATERAL TIBIADEVICE 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.