BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 48OD X 28ID

    MDR report key: 2823554 · Received June 18, 2010

    Report

    Report Number
    1818910-2010-10851
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS INC.
    Product Code
    JDL
    PMA / PMN Number
    K900832
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 OF THE LINER AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER 10D 48OD X 28ID 87JDL JDL DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS INC. NA 633110

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention