BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 56 OR 68ODX28ID

    MDR report key: 1143612 · Received August 28, 2008

    Report

    Report Number
    1818910-2008-03497
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE PATIENT WAS REVISED DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER 10D 56 OR 68ODX28ID 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA 584400005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention