BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 1844873 · Received September 22, 2010

    Report

    Report Number
    2249697-2010-01256
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THEY WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED BUT NOT MADE AVAILABLE. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE TRIATHLON-PS FEMORAL COMPONENT CEMENTED #4 RIGHT CAT # 5511-F-402, LOT UNKNOWN, WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S HETEROTOPIC OSSIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON COMMENTED THAT PT HAD HETEROTOPIC OSSIFICATION. AS A RESULT, PT HAD A LIMITED RANGE OF MOTION. HE REMOVED FEMOR AND INSERT. IMPLANTED TS FEMUR WITH CEMENTED STEM AND PS INSERT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention