BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2398396 · Received November 30, 2011

    Report

    Report Number
    3003998208-2011-00011
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Date of Event
    September 28, 2011
    Report Date
    November 4, 2011
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    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 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 WITCH THE PLACEMENT WAS GUIDED BY THE DEVICE. DURING SURGERY IT WAS NOTICED THAT THE FEMUR WAS IN HYPEREXTENSION AND THERE WAS NOTCH. ONE MONTH AFTER SURGERY THE PT HAS POOR JOINT STABILITY IN THE FRONTAL PLANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE N.V. 005970-000-02 11.672088

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR