BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 14011545 · Received April 5, 2022

    Report

    Report Number
    3005180920-2022-00247
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 MARCH 2022: LOT 122831: 50 ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 49 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018.

    Description of Event or Problem · 0

    AT 9 YEARS AND 4 MONTHS AFTER PRIMARY, THE SURGEON REVISED THE TIBIAL TRAY FIXED CEMENTED FOR IMPLANT SUBSIDENCE. THE REASON OF SUBSIDENCE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83569 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203L 122831 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention