BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS FEM 75MM LG RT

    MDR report key: 1071274 · Received July 7, 2008

    Report

    Report Number
    1818910-2008-02827
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE LOT NUMBERS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING, HOWEVER, THE LENGTH OF TIME IMPLANTED ( APPROX 23 YEARS) IS A POSSIBLE CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING, POLY WEAR AND OSTEOLYSIS. IT WAS REPORTED THAT THE POLY INSERT HAD FRACTURED INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS FEM 75MM LG RT 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA 604720

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention