BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS SL

    MDR report key: 1210197 · Received October 23, 2008

    Report

    Report Number
    9612771-2008-00069
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    April 5, 2007
    Report Date
    October 23, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A LACK OF BIOLOGICAL FIXATION TO THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS SL STEM KWY SMITH & NEPHEW ORTHOPAEDICS AG NA 0510.13.5462

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R