BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMA REVISION DISTAL STEM

    MDR report key: 1912905 · Received November 11, 2010

    Report

    Report Number
    1644408-2010-00600
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    October 30, 2010
    Report Date
    October 30, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD AN INFECTION. SURGEON REMOVED THE SHELL AND LINER WHICH WAS A STRYKER-OSTEONICS PART. THE SURGEON REPLACED THE LINER WITH A DJO XALT LINER. THE SURGEON REMOVED THE STEM, BUT RE-INSERTED AFTER CLEANING IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMA REVISION DISTAL STEM DISTAL STEM KWY ENCORE MEDICAL, L.P. 1003773

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention