BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 28ID

    MDR report key: 1253046 · Received December 4, 2008

    Report

    Report Number
    1818910-2008-05804
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K900832
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS AND WEAR OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 54OD X 28ID 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA 551950023

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention