BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

    MDR report key: 17670075 · Received September 1, 2023

    Report

    Report Number
    3005180920-2023-00684
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    March 7, 2022
    Report Date
    September 1, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVOLVED IMPLANTS: GMK-SPHERE 02.12.0210CRR TIBIAL INSERT FIXED SPHERE CR SIZE 2/10 MM R (K181635). GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988). GMK-SPHERE 02.12.1003R FEMORAL COMPONENT SPHERE CEMENTLESS SIZE 3 R (NOT REGISTERED AND MARKETED IN US).

    Description of Event or Problem · 0

    ON THE (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY DUE TO FLEXION DEFAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389613 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention