BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 11899737 · Received May 28, 2021

    Report

    Report Number
    3009532798-2021-00074
    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
    K163669
    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 AN INFECTION. HUMERAL STEM SIZE 14, Ø36 CENTERED GLENOSPHERE, Ø36+3 HUMERAL CUP, POST EXTENSION AND Ø24 GLENOID BASEPLATE WITH ASSOCIATED SCREWS WERE REMOVED AND REPLACED BY HUMERAL STEM SIZE 12, Ø40 CENTERED GLENOSPHERE, Ø40+9 HUMERAL CUP, POST EXTENSION AND Ø24 GLENOID BASEPLATE WITH ASSOCIATED SCREWS. PRIMARY SURGERY ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796121 HUMERIS REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS N1551

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R