BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTECH ANATOMIQUE

    MDR report key: 21557847 · Received March 10, 2025

    Report

    Report Number
    3009532798-2025-00014
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 10, 2025
    Manufacturer
    FX SHOULDER SOLUTIONS
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT TOOK PLACE OUTSIDE THE UNITED STATES (IN FRANCE) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE PATIENT WAS REVISED DUE TO A LOOSENING ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP, A GLENOSPHERE, A METAGLENE, A POST EXTENSION, SCREWS AND A STEM WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031966 EASYTECH ANATOMIQUE ANATOMIQUE SHOULDER PROSTHESIS HSD FX SHOULDER SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R