BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-PS TIBIAL INSERT #7 - 13MM

    MDR report key: 2020663 · Received March 7, 2011

    Report

    Report Number
    9610726-2011-00064
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.#9610726-2011-00065.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON REVISED THE ABOVE COMPONENTS BECAUSE THEY WERE KNOWN TO BE LOOSE AND PAINFUL AND SURGEON ADDED THEY WERE "HOT ON BONE SCAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-PS TIBIAL INSERT #7 - 13MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LR753

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention