BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERIS REVERSED

    MDR report key: 21935081 · Received April 30, 2025

    Report

    Report Number
    3014128390-2025-00017
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 30, 2025
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    PHX
    UDI-DI
    03701037300275
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVISION OCCURRED AFTER 7 MONTHS DUE TO DISSOCIATION OF COMPONENTS. NO ACTUAL, IMPLIED, OR SUSPECT LINK TO FX PRODUCT.

    Description of Event or Problem · 0

    REVISION OCCURRED APPROXIMATELY 7 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISSOCIATION OF GLENOSPHERE FROM THE BASEPLATE. 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 3 HUMERAL STABILITY CUP. THESE PARTS WERE REPLACED WITH A 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 9 HUMERAL STANDARD CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185585 HUMERIS REVERSED REVERSE SHOULDER PROSTHESIS PHX FX SHOULDER SOLUTIONS DALLAS U2368 03701037300275

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Hospitalization| R PART: 313-0903 LOT: T0919