BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION CONSTRAINED LINER LOCKING RING

    MDR report key: 1241102 · Received November 21, 2008

    Report

    Report Number
    1038671-2008-00054
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS UNDERGOING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    A TOTAL HIP ARTHROPLASTY WAS REVISED, DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVATION CONSTRAINED LINER LOCKING RING CONSTRAINED LINER LOCKING RING KWB EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R