BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 8256602 · Received January 17, 2019

    Report

    Report Number
    3005180920-2018-01103
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 18, 2018
    Report Date
    January 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2019: LOT 171143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2017. EXPIRATION DATE: 2022-05-30. 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 DUE TO INSTABILITY CAUSED BY ASEPTIC LOOSENING OF THE TIBIAL TRAY 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND IMPLANTED A CEMENTLESS EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS DISCOVERED THAT NO CEMENT WAS ATTACHED TO THE UNDER-SURFACE/KEEL OF THE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50918 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 171143 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention