BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 9774076 · Received March 2, 2020

    Report

    Report Number
    3009532798-2020-00096
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 21, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    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

    REVISION SURGERY OCCURRED (B)(6) 2020 FOR AN UNKNOWN REASON. ALL PRODUCT FX SOLUTIONS WERE REMOVED : HUMERAL STEAM SIZE 12, DOUBLE TAPER, CENTERED HEAD, 3-4 PEGS GLENOID. PRIMARY SURGERY OCCURRED IN 2019. AS FAR AS WE KNOW, IT HAS BEEN HIGHLIGHTED DURING THE REVISION SURGERY THAT THE GLENOID WAS UNSEALED (UNKNOWN REASON). ALL THE COMPONENT PART OF THE PROTHESIS WERE REMOVED, THE REPLACEMENT PRODUCTS ARE NOT FX PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238580 HUMERIS SHOULDER PROTHESIS HSD FX SOLUTIONS M0945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R