BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 4106043 · Received September 16, 2014

    Report

    Report Number
    3003998208-2014-00008
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K091263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION AND THE DEVICE DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. THE REC'D INFO INDICATES THAT THE ANGEL WING WAS USED TO VERIFY THE CUTS AND CONFIRMED THAT NO NOTCHING WAS DETECTED PRIOR TO MAKING THE CUT. THEREFORE, THE NOTCHING WAS MOST LIKELY NOT CAUSED BY THE GUIDE BUT RATHER BY ACTIONS PERFORMED AFTER PIN PLACEMENT. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENTS GUIDES. AFTER CUTTING, THE SURGEON NOTICED A NOTCH OF 5 MM IN THE FEMUR. THE COMPLAINANT REPORTED THE ANTERIOR CUT WAS VERIFIED USING AN ANGEL WING PRIOR TO MAKING THE CUT. THERE WAS NO PATIENT INJURY/HARM, NO BLOOD LOSS, NO SURGICAL DELAY REPORTED. NO INTERVENTION OR ADD'L SURGERY ARE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573885 ZIMMER PATIENT SPECIFIC INSTRUMENT KNEE PROSTHESIS MBH MATERIALISE N.V. 00-5970-000-02 14.038354

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability