BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 9791234 · Received March 5, 2020

    Report

    Report Number
    3009532798-2020-00142
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 4, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    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 DUE TO AN INFECTION OCCURRED (B)(6) 2020. 36+3 HUMERAL CUP, 6 GLENOSPHERE AND 36/14 HUMERAL STEAM WERE REMOVED AND REPLACED BY AN ANTIBIOTIC IMPREGNATED SPACER (NO FX). PRIMARY SURGERY OCCURRED IN 2017 (DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254016 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS K1788

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R