BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 11930752 · Received June 3, 2021

    Report

    Report Number
    3014128390-2021-00030
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 3, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2021 DUE TO DISLOCATION, APPROXIMATELY 1 MONTH AFTER PRIMARY SURGERY. SURGEON EXPLANTED THE 36/+9 STANDARD HUMERAL CUP AND REPLACED IT WITH A 36/+6 STANDARD HUMERAL CUP, AND THEN SURGEON ADDED TWO CORTICAL SCREWS FOR ADDITIONAL STEM FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832484 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS N1431

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R