BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 52OD

    MDR report key: 1754342 · Received July 8, 2010

    Report

    Report Number
    1818910-2010-04367
    Event Type
    Injury
    Date Received
    July 8, 2010
    Report Date
    June 8, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 POTENTIAL ALVAL. AFTER THE PRIMARY SURGERY, THE PATIENT SUFFERED FROM PSEUDOTUMOR, TUMOR, AND THE PAIN IN THE FEMUR. THE PATIENT'S LEVEL OF ADL IS LOW. PATCH TEST WAS DONE. BLACK FOREIGN MATTER WAS NOTED IN THE HEAD JUNCTION OF THE STEM NECK. THE TISSUE AROUND THE SLIDING SURFACES IN THE JOINT CAPSULE WERE FOUND NECROSIS AND SCARED, AND NO BLEEDING WAS NOTED. PSEUDOTUMOR WAS FOUND THROUGH CT IN INNER CAVITY OF PELVIS. BLEEDING WAS NOTED AFTER CLEAR LIQUID FROM THE HOLES MADE BY K-WIRE IN THE PROXIMAL PART OF FEMUR AND PERIARTICULAR SITE. GRANULATION TISSUE LIKE FIBROUS MEMBRANE WAS FOUND AND A PIECE OF IT WAS COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTAMET MTL INS NEUT 36MM 52OD 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2480656

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention