BEUDAMED
    FDA Adverse Event Injury Summary report: N

    +4 ENDURON LN 28IDX62 OR 74OD

    MDR report key: 1080899 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02806
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +4 ENDURON LN 28IDX62 OR 74OD 87HRY HRY DEPUY INTERNATIONAL, LTD. NA T5FB91

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention