BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 12431689 · Received September 7, 2021

    Report

    Report Number
    3005180920-2021-00721
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 7, 2021
    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 WAS PERFORMED ON 12.AUG.2021: LOT 1910493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-MAY-2020. EXPIRATION DATE: 2025-APR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE OF THE LOOSE TIBIA IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331233 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1204L 1910493 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention