BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 60 OR 72ODX28ID

    MDR report key: 1222439 · Received November 4, 2008

    Report

    Report Number
    1818910-2008-05127
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 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
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR 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

    PT WAS REVISED TO ADDRESS CHRONIC DISLOCATION (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 60 OR 72ODX28ID 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA 676290006

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention