BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 8773099 · Received July 9, 2019

    Report

    Report Number
    3014128390-2019-00022
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 9, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY OCCURRED THE SAME DAY AS (IMMEDIATELY FOLLOWING) THE PRIMARY SURGERY. THE PATIENT CAME OUT OF THE PRIMARY SURGERY AND IMMEDIATELY DISLOCATED WHILE IN THE RECOVERY ROOM. THE PATIENT WAS THEN TAKEN BACK INTO THE OPERATING ROOM. THE DOCTOR REVISED THE HUMERAL COMPONENTS, EXPLANTING THE SIZE 12 HUMERAL STEM (REF 317-3212), THE 36/+9 HUMERAL CUP (REF 103-0809), AND THE +9MM HUMERAL SPACER (REF 103-0007). THE SURGEON THEN IMPLANTED NEW HUMERAL COMPONENTS: A SIZE 14 HUMERAL STEM (REF 317-3614), A +9MM SPACER (REF 103-0007), AND A 36/+6 HUMERAL CUP (REF 103-0806).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567860 HUMELOCK REVERSED REVERSE SHOULDER PROSTHESIS PHX FX SOLUTIONS M0066

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R