BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE BAL SIZER DISTRACTOR

    MDR report key: 3931137 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23238
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THAT AFTER SURGERY WHILE TRYING TO REASSEMBLE TRAYS, THE REP DISCOVERED THE TWO PIECES OF BALANCED SIZER COLD WELDED TOGETHER. FOLLOWING INSPECTION OF THE RETURNED DEVICE THE ROOT CAUSE WAS ATTRIBUTED TO PRODUCT DESIGN. IF THE IFU IS NOT FOLLOWED APPROPRIATELY THEN THIS RENDERS THE DEVICE NOT AS ROBUST. THE MATERIAL OF THE HANDLE HAS BEEN ALTERED TO REDUCE THE CHANCE OF GALLING VIA ECO425544. IT IS UNLIKELY THERE IS A MANUFACTURING FAULT. IT SHOULD BE NOTED THAT THIS PRODUCT IS FROM A BATCH PREVIOUS TO THE IMPLEMENTATION OF ECO425544. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AFTER SURGERY WHILE TRYING TO REASSEMBLE TRAYS, THE REP DISCOVERED THE TWO PIECES OF BALANCED SIZER COLD WELDED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411068 ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. ABB25485

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR