BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 10913492 · Received November 27, 2020

    Report

    Report Number
    3005180920-2020-00837
    Event Type
    Injury
    Date Received
    November 27, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 NOVEMBER 2020. LOT 162179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2016. EXPIRATION DATE: 2021-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, REPORTING INSTABILITY DUE TO A LOOSE TIBIAL COMPONENT. THE CAUSE OF THE LOOSE TIBIA IS UNKNOWN. THE SURGEON REVISED THE TIBIAL COMPONENT, FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378009 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 L CEMENTED FIXED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1204L 162179 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention