BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON CNSTR TIB INS SML 9MM

    MDR report key: 1844654 · Received September 20, 2010

    Report

    Report Number
    2249697-2010-01240
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910235
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "ORIGINAL TIBIA INSERT WAS TAKEN OUT NEW TIBIA INSERT WAS PUT IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON CNSTR TIB INS SML 9MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UDRGA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention