BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS 3-PEG POLY PAT TR PINS SM+

    MDR report key: 6041514 · Received October 19, 2016

    Report

    Report Number
    1818910-2016-29808
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 10, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED THE PIN COMPONENT IS MISSING. THE DEVICE PIN IS A PRESS FIT AND WILL SECURE THE TWO HALVES PROPERLY. THE DIAMETER OF THE HOLE IN THE METAL BACKING PLATE WAS MEASURED AND FOUND TO MEET THE SPECIFICATION LIMITS PER THE DRAWING. MEASUREMENT OF THE PIN COULD NOT BE DONE AS THE DIS-ASSEMBLED PIN WAS NOT SUPPLIED AS PART OF THE COMPLAINT. WITH THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THIS COMPLAINT CAN'T BE DEFINITIVELY DETERMINED. NO EVIDENCE WAS FOUND INDICATING DESIGN OR MANUFACTURE ERROR WERE CONTRIBUTING FACTORS AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. MONITOR REPORTS OF DISASSEMBLED PIN COMPONENTS THROUGH (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    RETAINING PIN HOLDING THE METAL BACKING AND TRIAL FACE HAS COME OUT.

    Description of Event or Problem · 1

    RETAINING PIN HOLDING THE METAL BACKING AND TRIAL FACE HAS COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693159 LCS 3-PEG POLY PAT TR PINS SM+ N/A LXH DEPUY ORTHOPAEDICS, INC. B4WGR1000

    Patients

    Seq Age Sex Outcome Treatment
    1