BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 13MM

    MDR report key: 1982222 · Received January 25, 2011

    Report

    Report Number
    9610726-2011-00012
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K063423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE IMPLANT WAS REMOVED AND REPLACED DURING AN I&D OF THE KNEE DUE TO A SUPERFICIAL INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INSERT #5 13MM IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention