BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II

    MDR report key: 11899735 · Received May 28, 2021

    Report

    Report Number
    3009532798-2021-00073
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 28, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2021 DUE TO A LOOSENING. Ø36 CENTERED GLENOSPHERE, Ø36+3 HUMERAL CUP AND Ø24 GLENOID BASEPLATE WITH ASSOCIATED SCREWS WERE REMOVED AND REPLACED BY Ø40 CENTERED GLENOSPHERE, Ø40+6 HUMERAL CUP AND Ø24 GLENOID BASEPLATE WITH ASSOCIATED SCREWS. PRIMARY SURGERY ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796119 HUMELOCK II REVERSED SHOUDLER PROTHESIS PHX FX SOLUTIONS P1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R