BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 12333092 · Received August 17, 2021

    Report

    Report Number
    3014128390-2021-00042
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 27, 2021
    Report Date
    August 18, 2021
    Manufacturer
    FX SOLUTIONS SAS
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT SUBMITTED TO CORRECT MEDICAL DEVICE CATALOG NUMBER IN SECTION D. THE CORRECT CATALOG NUMBER FOR THE SUSPECT DEVICE IS 103-0007.

    Description of Event or Problem · 0

    PATIENT REVISED ON (B)(6) 2021 DUE TO HUMERAL SPACER DISASSOCIATING FROM HUMERAL STEM. COMPONENTS IMPLANTED ON (B)(6) 2021. SURGEON EXPLANTED 36/+9 STABILITY HUMERAL CUP AND +9MM HUMERAL SPACER, AND THEN IMPLANTED A NEW 36/+9 STABILITY HUMERAL CUP AND NEW +9MM HUMERAL SPACER.

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2021 DUE TO HUMERAL SPACER DISASSOCIATING FROM HUMERAL STEM. COMPONENTS IMPLANTED ON (B)(6) 2021. SURGEON EXPLANTED 36/+9 STABILITY HUMERAL CUP AND +9MM HUMERAL SPACER, AND THEN IMPLANTED A NEW 36/+9 STABILITY HUMERAL CUP AND NEW +9MM HUMERAL SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229666 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS SAS P0258

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R