BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS TIBIAL INSERT TRIAL #4 - 9MM

    MDR report key: 2142641 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00932
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, "RIGHT TOTAL KNEE REPLACEMENT. DURING SURGERY, TRIAL INSERT BROKE DURING INSERTION. SALES REP OPENED ANOTHER TRAY TO COMPLETE TRIALING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS TIBIAL INSERT TRIAL #4 - 9MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA PPM1Z29

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other