BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 11654996 · Received April 13, 2021

    Report

    Report Number
    3014128390-2021-00013
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 12, 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 GLENOSPHERE DISASSOCIATION APPROXIMATELY 2 YEARS AFTER PRIMARY SURGERY. SURGEON EXPLANTED THE 36MM CENTERED GLENOSPHERE WITH SCREW AND 135/145 36/+3 STANDARD HUMERAL CUP, AND THEN IMPLANTED A NEW 36MM CENTERED GLENOSPHERE WITH SCREW AND 135/145 36/+9 STABILITY HUMERAL CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552533 HUMERIS REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS M1319

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R