BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT PS#7 9MM

    MDR report key: 4243444 · Received November 11, 2014

    Report

    Report Number
    0002249697-2014-04239
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED ON LEFT KNEE DUE TO INFECTION. DOCTOR DID AN I&D AND REMOVED INSERT. SALES REP ALSO REPORTED, THE DOCTOR LEFT BEHIND THE LOCKING WIRE OF INSERT AND DID NOT SEE IT UNTIL POST-OP. PATIENT WAS THEN TAKEN BACK TO OR TO REMOVED THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725794 X3 TRIATHLON INSERT PS#7 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention