BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 54OD X 28ID

    MDR report key: 2002927 · Received February 16, 2011

    Report

    Report Number
    1818910-2011-02126
    Event Type
    Injury
    Date Received
    February 16, 2011
    Report Date
    January 17, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 54OD X 28ID 87HRY; 87HSX; 87JDB; 87JDI; 87JWH; 87KWA; 87KWT LPH DEPUY ORTHOPAEDICS, INC. NA R56TN1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention