BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3202166 · Received June 28, 2013

    Report

    Report Number
    3003998208-2013-00007
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    JWH
    PMA / PMN Number
    K091263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. THE DEVICE WAS MADE ACCORDING TO THE PRE-OPERATIVE PLAN 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/OR THE DEVICE BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE ANTERIOR CUT TO PLACE THE FEMORAL IMPLANT, WAS PERFORMED WITH A CUT BLOCK OF WHICH THE PLACEMENT WAS GUIDED BY THE DEVICE. A NOTCH OF 2-3MM IN THE ANTERIOR CUT FOR THE FEMUR WAS NOTICED DURING SURGERY AFTER THE CUT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297127 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH JWH MATERIALISE N.V. 00-5970-000-01 56560552

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR