BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 56MM

    MDR report key: 2920252 · Received December 17, 2012

    Report

    Report Number
    2249697-2012-02710
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PUTTING IN ONE OF THE BLACK 56MM WINDOW TRIALS TO CHECK THE POSITIONING AND WHEN THE SURGEON TRIED TO REMOVE IT, THE TRIAL WAS IN VERY WELL AND WOULD NOT COME OUT. SURGEON TRIED USING AN INSERTER TO TRY AND LEVER THE TRIAL OUT AND THE TRIAL STILL WOULD NOT COME OUT SO SURGEON TRIED A BONE TAMP TO REMOVE THE TRIAL AND WAS SUCCESSFUL HOWEVER THE TRIAL NOW UNUSABLE AS THE TRIAL NOW HAS SHARP EDGES AS A RESULT OF ATTEMPTING TO REMOVE THE TRIAL. THIS HAPPENED DURING A RIGHT SIDE TOTAL HIP AND ANTERIOR APPROACH WAS USED FOR SURGERY. SURGEON IMPLANTED A TRITANIUM ACETABULAR CUP AND AN ACCOLADE II STEM. THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO PT OR USER AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACET WINDOW TRIAL 56MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SS108246

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other