BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 52OD

    MDR report key: 2961423 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12363
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 INFECTION AND PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65851 ULTAMET MTL INS NEUT 36MM 52OD METAL INSERT KWA DEPUY INTERNATIONAL LTD. REG. # 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention