BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CR FEM TRIAL SZ 6 LT

    MDR report key: 4811560 · Received June 2, 2015

    Report

    Report Number
    1818910-2015-22444
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 21, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REMAINS CLOSED, AS THE ADDED INFORMATION DOES NOT CHANGE THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TRIAL BREAKAGE. A COMPLAINTS REVIEW WAS COMPLETED IN FEBRUARY 2014 AND IN JUNE 2014 FOR ALL ATTUNE TRIAL INSTRUMENTS, FOLLOWING (B)(4) SURGERIES, INCLUSIVE OF THE ATTUNE FEMORAL TRIALS, ARTICULATION SURFACE TRIALS, AND THE PATELLA TRIALS. FINDINGS OF THE COMPLAINTS REVIEW PROMPTED DFMEA UPDATES WHERE APPLICABLE. THE ROOT CAUSE IS ATTRIBUTED TO USER TECHNIQUE AND/OR MISUSE. THE DAMAGE SUGGESTS THE TRIAL WAS PRYED OR OTHERWISE INAPPROPRIATELY REMOVED DURING TRIALING. BASED ON THE ROOT CAUSE OF SUSPECTED MISUSE, CORRECTIVE ACTION IS NOT NEEDED. MONITOR SUBSEQUENT REPORTS VIA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    ATTUNE CR FEMORAL TRIAL IS BROKEN INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354475 ATTUNE CR FEM TRIAL SZ 6 LT KNEE INSTRUMENT/TRIAL JWH DEPUY ORTHOPAEDICS, INC. MVMBWD000

    Patients

    Seq Age Sex Outcome Treatment
    1