BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVATION CERAMIC CLUSTER HOLE SHELL

    MDR report key: 4213632 · Received September 25, 2014

    Report

    Report Number
    1038671-2014-00505
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    February 18, 2014
    Report Date
    September 25, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REVISION OF HIP COMPONENTS DUE TO A FRACTURED HIP LINER APPROX 2 YEARS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596611 NOVATION CERAMIC CLUSTER HOLE SHELL CLUTER HOLE SHELL KWB EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O