BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION

    MDR report key: 1882557 · Received October 26, 2010

    Report

    Report Number
    1020279-2010-00299
    Event Type
    Injury
    Date Received
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSERT DISASSOCIATED FROM THE TIBIAL BASEPLATE. IT IS UNKNOWN IF A REVISION SURGERY HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGION TIBIAL INSERT JWH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R