BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIGMA DIST FEMAUG TRL4MM S4

    MDR report key: 5491994 · Received March 10, 2016

    Report

    Report Number
    1818910-2016-15070
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 15, 2016
    Report Date
    February 15, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, D FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE PRODUCT LOT CODE WAS NOT PROVIDED. A COMPLAINT DATABASE SEARCH AGAINST PRODUCT CODE 961680 DID NOT REVEAL ANY TREND OF BREAKAGE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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

    THE AUGMENT TRIAL LOCKING RING BROKE OFF DURING TOTAL KNEE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147915 PFCSIGMA DIST FEMAUG TRL4MM S4 KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR