BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2690735 · Received August 8, 2012

    Report

    Report Number
    3003998208-2012-00011
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 12, 2012
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION AND AN EVAL OF THE RETURNED DEVICE DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE BE RETURNED FOR EVAL 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
    1 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE N.V. 00-5970-000-02

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR