TOTAL KNEE
Received May 2, 1994 · Event occurred Apr 15, 1994
Report 33274-1994-00014 · MDR key 8091
Device
Generic name
Pca Total Knee Sm Baseplate
Manufacturer
Howmedica, Inc.Catalog number
6638-1-790
Lot number
HCKVB
Patient
79 YR
Narrative
Description of Event or Problem
PT COMPLAINED OF PAIN IN RIGHT KNEE - X-RAYS SHOWED TIBIAL COMPONENT WAS IN SLIGHT VAARUS POSITION.DEVICE 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.