BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 11931297 · Received June 3, 2021

    Report

    Report Number
    3014128390-2021-00034
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 18, 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 REVISED ON (B)(6) 2021 DUE TO DISLOCATION (NON-COMPLIANCE WITH POST-OPERATIVE INSTRUCTIONS) APPROXIMATELY 1 MONTH AFTER PRIMARY SURGERY. SURGEON EXPLANTED A 40/+3 STANDARD HUMERAL CUP AND REPLACED IT WITH A 40/+6 STABILITY HUMERAL CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832537 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS L2856

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R