BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 11937906 · Received June 4, 2021

    Report

    Report Number
    3009532798-2021-00086
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 4, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K192206
    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 POOR BONE QUALITY APPROXIMATELY 4.5 MONTHS AFTER PRIMARY SURGERY. SURGEON CONVERTED THE REVERSE TO A HEMI, EXPLANTING ALL COMPONENTS EXCEPT FOR THE STEM (32/+3 STANDARD HUMERAL CUP, 32MM CENTERED GLENOSPHERE WITH SCREW, 24MM GLENOID BASEPLATE, +6MM POST EXTENSION, AND 4 STANDARD SCREWS) AND THEN IMPLANTING A 24/10 ECCENTRIC TAPER ADAPTER AND 43X16 COCR CENTERED HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833372 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R