BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 28MM +4 10D LINER

    MDR report key: 2012630 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02829
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    PT WAS REVISED TO ADDRESS POLY WEAR OF THE LINER AND OSTEOLYSIS IN THE PROXIMAL FEMUR. IT WAS NOTED THAT THE LINER WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY 28MM +4 10D LINER TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention