BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4730

    MDR report key: 4730 · Received July 31, 1992

    Report

    Report Number
    4730
    Event Type
    Malfunction
    Date Received
    July 31, 1992
    Date of Event
    April 6, 1992
    Report Date
    July 27, 1992
    Manufacturer
    OSTEONICS
    Product Code
    KIG
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL WRIST PROSTHESIS REMOVED AND REPLACED DUE TO FAILURE. CAUSE OF FAILURE ON PATHOLOGIST'S EXAMINATION WAS THAT THE HIGH DENSITY POLYETHYLENE HINGE SHOWED WEAR. THE PROSTHESIS MEASURED 8.5 CM BY 1.7 X 0.5 CMINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: END OF LIFE - PREMATURE, MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIG OSTEONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other