BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS FEM 75MM LG LT

    MDR report key: 1080888 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02694
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/R44
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE PRODUCT CODE AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. THE NEED FOR CORRECTIVE ACTION IS NO INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS A FEMORAL COMPONENT THAT HAD FRACTURED ON THE MEDIAL CONDYLE (LEFT SIDE). POLY WEAR AND OSTEOLYSIS WERE ALSO FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS FEM 75MM LG LT 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention