BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS PRECISION FEMORAL PREP KIT SIZE 4

    MDR report key: 1962857 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01878
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "#4 PRECISION OPEN CHAMFER BLOCK WAS PLACED ON DISTAL FEMUR A CUT WAS MADE ON THE ANTERIOR CHAMFER. THE CUT EXTENDED TOO LONG ON THE BONE. THE NOTCH BLOCK WAS PLACED ON THE BONE AND THERE WAS A LARGE GAP AT THE ANTERIOR CHAMFER INTERFACE. THE SURGEON RECUT TO ACCOMMODATE THE NOTCH BLOCK. PLEASE CHECK SPECIFICATIONS ON #4 PRECISION OPEN CHAMFER. NO PT HARM. FEMUR FIT CORRECTLY AND PROCEDURE WAS CONTINUED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS PRECISION FEMORAL PREP KIT SIZE 4 INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 131010-01

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other