BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION EXTENSION STEM - FLUTED Ø 16 L 65

    MDR report key: 17395198 · Received July 26, 2023

    Report

    Report Number
    3005180920-2023-00565
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030823022
    PMA / PMN Number
    K120790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 1904822: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2019. EXPIRATION DATE: 2024-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR PERI-PROSTHETIC TIBIAL FRACTURE, AT TIBIAL STEM LEVEL, ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY. TIBIAL COMPONENTS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604868 GMK-REVISION EXTENSION STEM - FLUTED Ø 16 L 65 KNEE REVISION SYSTEM EXTENSION STEM JWH MEDACTA INTERNATIONAL SA 1904822 07630030823022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention