BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR PRECISION FEMORAL PREP KIT SIZE 5

    MDR report key: 1233917 · Received November 14, 2008

    Report

    Report Number
    2249697-2008-00370
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    I T WAS REPORTED THAT, "THE INSERT WAS USED AS A SPACER IN THE FIRST STAGE OF A TWO STAGE REVISION PROCEDURE FOR A KNOWN PERPROSTHETIC INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CR PRECISION FEMORAL PREP KIT SIZE 5 INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 161007-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention