BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 19644101 · Received July 1, 2024

    Report

    Report Number
    3009532798-2024-00074
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 1, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS
    Product Code
    PHX
    UDI-DI
    03701037300107
    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 INSTABILITY ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP WAS EXPLANTED. A CUP AND A REVERSED ADAPTER WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572218 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SHOULDER SOLUTIONS U1014 03701037300107

    Patients

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