BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 1982219 · Received January 24, 2011

    Report

    Report Number
    2249697-2011-00085
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETURNED TO THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. HOSPITAL PROTOCOL DOES NOT ALLOW FOR X-RAYS OR RETURN OF PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON EXCHANGED POLY TO THICKER X-3 TO IMPROVE PATIENT STABILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA DRXMKA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention