BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 13899065 · Received March 25, 2022

    Report

    Report Number
    3009532798-2022-00007
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 11, 2022
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    UDI-DI
    03701037300145
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE PATIENT WAS REVISED ON (B)(6) 2022 FOR INFECTION. APPROXIMATELY 2 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLE,OID BASEPLATE, 2 STANDARD SCREW (35MM AND 40MM), 1 POST EXTENSION +10MM, 1 HUMERAL SPACER AND 1 HUMERAL CUP 40+9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885059 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS 104-0809 J340 03701037300145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization