BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #2 9MM

    MDR report key: 1932976 · Received December 15, 2010

    Report

    Report Number
    9610726-2010-00469
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR#: 9610726-2010-00470.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "LOOSE FEMUR, FEMUR WAS REVISED TO A TS. POLY WAS EXTRACTED. SURGEON MENTIONED UNUSUAL POLY WEAR. PATIENT FELL IN 2009."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INSERT #2 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LAM827

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention