BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 2942310 · Received January 8, 2013

    Report

    Report Number
    9610726-2013-90008
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    HOWMEDICA INTERNATIONAL S. DE R.L.,
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER¿S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE OUTER BLISTER OF IMPLANT IT WAS NOTED THAT INNER BLISTER APPEARED TO HAVE BEEN SMASHED INTO THE OUTER BLISTER. ANOTHER COMPONENT OF THE SAME TYPE WAS OPENED AND IMPLANTED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10306 TRIATHLON PS FEM COMPONENT, CEMENTED IMPLANT JWH HOWMEDICA INTERNATIONAL S. DE R.L., NA GIZW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA