BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 11938023 · Received June 4, 2021

    Report

    Report Number
    3009532798-2021-00080
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 4, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR HAS ALREADY BEEN SUBMITTED TO FDA BY THE US IMPORTER WITH REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2021 DUE TO GLENOSPHERE DISASSOCIATION FROM FALL, APPROXIMATELY 3 MONTHS AFTER PRIMARY SURGERY. SURGEON EXPLANTED THE 40MM CENTERED GLENOSPHERE WITH SCREW AND REPLACED IT WITH A NEW COMPONENT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833377 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS L2570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R