BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE4 11MM

    MDR report key: 2171356 · Received July 18, 2011

    Report

    Report Number
    9610726-2011-00256
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IF WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT HAD AN EPISODE OF GASTRO 6 WEEKS PRIOR TO PROCEDURE AND AFTER THAT, WAS COMPLAINING OF PAIN IN THEIR KNEE, ELEVATED ESR. TRIATHLON INSERT WAS REMOVED, LEFT KNEE JOINT WAS WASHED OUT AND A REPLACEMENT INSERT WAS IMPLANTED. ALL OTHER IMPLANTS REMAIN INSITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INS SIZE4 11MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LBY046

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention