BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 21397120 · Received February 18, 2025

    Report

    Report Number
    3009532798-2025-00008
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 17, 2025
    Manufacturer
    FX SHOULDER SOLUTIONS
    Product Code
    PHX
    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 AN INFECTION ON (B)(6) 2025. THE IMPLANTATION DATE UNKNOWN. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179788 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SHOULDER SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H