BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON AR FEMORAL ALIGNMENT GUIDE

    MDR report key: 2002256 · Received February 4, 2011

    Report

    Report Number
    2249697-2011-00124
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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, "A PIN WAS BENT WHILED PUTTING IN THE LEFT HOLES OF THE ALIGNMENT GUIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON AR FEMORAL ALIGNMENT GUIDE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA P1H94

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other