BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II

    MDR report key: 11946194 · Received June 7, 2021

    Report

    Report Number
    3009532798-2021-00091
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 7, 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 FOR A SECOND TIME DUE TO A DISLOCATION ON (B)(6) 2021. Ø36 CENTERED GLENOSPHERE, Ø36+6 HUMERAL CUP AND Ø24 GLENOID BASEPLATE WITH ASSOCIATED SCREWS WERE REMOVED AND REPLACED BY Ø40 CENTERED GLENOSPHERE, Ø40+3 HUMERAL CUP, POST EXTENSION AND Ø24 GLENOID BASEPLATE WITH ASSOCIATED SCREWS. PRIMARY SURGERY ON (B)(6) 2021 AND FIRST REVISION SURGERY ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841455 HUMELOCK II REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS P0871

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R