BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 11766247 · Received May 3, 2021

    Report

    Report Number
    3014128390-2021-00025
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 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 APPROXIMATELY 6 MONTHS AFTER PRIMARY SURGERY. SURGEON CONVERTED THE REVERSE TO A HEMI, EXPLANTING ALL COMPONENTS EXCEPT FOR THE STEM (32MM CENTERED GLENOSPHERE WITH SCREW, 24MM GLENOID BASEPLATE, 32/+9 STANDARD HUMERAL CUP, +6MM POST EXTENSION, AND 2 BASEPLATE LOCKING SCREWS), AND THEN IMPLANTING A 50X20 OFFSET HUMERAL HEAD AND A 24/10 ECCENTRIC TAPER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655745 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS N3246

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R