BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY II BCS

    MDR report key: 3180782 · Received June 20, 2013

    Report

    Report Number
    1020279-2013-00324
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO POLY CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281493 JOURNEY II BCS JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM JWH SMITH & NEPHEW, INC. 12MM12226

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4)| (B)(4)