BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R

    MDR report key: 19389764 · Received May 24, 2024

    Report

    Report Number
    3005180920-2024-00326
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2024 LOT 172753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEPT-2017. EXPIRATION DATE: 2022-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 6 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657725 GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 172753 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention