BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 20222571 · Received September 16, 2024

    Report

    Report Number
    3009532798-2024-00098
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 12, 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 DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638993 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SHOULDER SOLUTIONS U1654 03701037300107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R