BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER TRIATHLON KNEE SYSTEM

    MDR report key: 3070359 · Received April 12, 2013

    Report

    Report Number
    3070359
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPEDICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A LEFT TOTAL KNEE ARTHROPLASTY, IMAGE GUIDED USING STRYKER TRIATHLON KNEE SYSTEM, #4 FEMORAL COMPONENT AND #5 TIBIAL COMPONENT, A 13 MM TIBIAL BEARING CS COMPONENT, 39 MM PATELLAR COMPONENT. UPON REMOVAL OF THE PINS FOR THE TRACKERS, THE FEMORAL PINS CAME OUT EASILY. THE TIBIAL PINS WERE HARDER TO GET OUT AND WHEN THEY WERE REMOVED, LESS THAN A QUARTER INCH OF THE PIN WAS LEFT IN THE BONE, MOST LIKELY IN THE POSTERIOR TIBIAL SURFACE. IT IS TECHNICALLY A COMPLICATION OF PIN BREAKAGE BUT IT SHOULD NOT CAUSE ANY DIFFICULTIES AND THERE IS NO NEED TO REMOVE THIS SMALL PIECE OF METAL. BOTH PINS DID BREAK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT TOTAL KNEE ARTHROPLASTY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158431 STRYKER TRIATHLON KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM JWH STRYKER ORTHOPEDICS * *
    158432 ORTHOLOCK EX-PIN 3X1 10 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, PIN JWH STRYKER ORTHOPEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR