BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS COMPLETE FEM CEM L LG

    MDR report key: 7902436 · Received September 24, 2018

    Report

    Report Number
    1818910-2018-70210
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    May 21, 2018
    Report Date
    August 31, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295021643
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE 'LIFT HERE' STERILE TABS ON THE PACKAGING TORE OFF (TIBIAL TRAY) AND STARTED TO TEAR AWAY (FEMORAL COMPONENT) (AS LISTED ABOVE) WHEN LIFTING THE IMPLANTS FROM THE NON-STERILE PACKAGING WITH ARTERY FORCEPS WITH THE 'LIFT HERE' TAB. STERILE FIELD WAS NOT COMPROMISED AND NO ISSUE OR DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743493 LCS COMPLETE FEM CEM L LG LCS COMPLETE : KNEE FEMORAL NJL DEPUY ORTHOPAEDICS INC US 8588160 10603295021643

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR