BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2488004 · Received March 6, 2012

    Report

    Report Number
    3003998208-2012-00005
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    November 29, 2012
    Report Date
    February 9, 2012
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION 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 BECOMES 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

    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 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. 00-5970-000-03 56524375

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR