BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 11930755 · Received June 3, 2021

    Report

    Report Number
    3014128390-2021-00031
    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 UNDERWENT REMOVAL OF PROSTHESIS DUE TO INFECTION ON (B)(6) 2021, APPROXIMATELY 3 WEEKS AFTER PRIMARY SURGERY. SURGEON EXPLANTED ALL COMPONENTS INCLUDING SIZE 14 CEMENTLESS HUMERIS STEM, 135/145 36/+9 STABILITY HUMERAL CUP, 36MM CENTERED GLENOSPHERE WITH SCREW, 24MM BASEPLATE WITH CENTRAL SCREW, AND 4 LOCKING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832485 HUMERIS REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS M0864

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R