BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPOLAR

    MDR report key: 1052810 · Received May 27, 2008

    Report

    Report Number
    1020279-2008-00160
    Event Type
    Injury
    Date Received
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIPOLAR TAPER SLEEVE KWY SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA 07DM18107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R