BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3919302 · Received March 10, 2014

    Report

    Report Number
    3003998208-2014-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. THE PRE-OPERATIVE PLAN WAS REVIEWED AND APPROVED BY THE PHYSICIAN. THE RECEIVED INFORMATION INDICATES THE ANGEL WING WAS NOT USED TO VERIFY ABSENCE OF NOTCHING AS INDICATED IN THE SURGICAL TECHNIQUE. A DEFINITIVE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION 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

    NEEDED TO TAKE AN ADDITIONAL 2 MM DISTAL CUT. DECREASED FEMORAL RESECTION RESULTED IN NOTCHING OF THE ANTERIOR FEMORAL CORTEX. A 20 MINUTE DELAY WAS REPORTED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143053 ZIMMER PATIENT SPECIFIC INSTRUMENT KNEE PROSTHESIS MBH MATERIALISE N.V. 00-5970-000-03 5658222

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR