BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 1865086 · Received October 5, 2010

    Report

    Report Number
    2249697-2010-01315
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: "INSERT WOULD NOT SEAT INTO BASEPLATE PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MJMRW0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other