BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR EXTRACTOR

    MDR report key: 2883463 · Received November 14, 2012

    Report

    Report Number
    2249697-2012-02329
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A BILATERAL KNEE PROCEDURE THIS INSTRUMENT WAS USED TO IMPACT THE FEMORAL COMPONENT IN BOTH KNEES. WHEN LOADING THE 2ND FEMORAL COMPONENT ONE ARM WAS OBVIOUSLY LOOSE BUT STILL WORKED TO HOLD THE PROSTHESIS. AFTER IMPACTION WAS NOTED THAT 2 BOLTS, RIVETS WERE MISSING FROM THE INSTRUMENT AND NEEDED TO BE FOUND AS OTHERWISE THEY COULD BE IN THE PTS WOUND. BOTH WERE FOUND, ONE ON THE FLOOR AND ONE IN THE INSTRUMENT TRAY. THERE WAS A DELAY OF 15 MINS AS A RESULT. THE SURGEON REQUIRED THE PT HAVE AN XRAY IN THE OPERATING ROOM PRIOR TO WOULD CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL IMPACTOR EXTRACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA RD5S097

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other