BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2329663 · Received October 21, 2011

    Report

    Report Number
    3003998208-2011-00004
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    July 21, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    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 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. THIS REPORTABLE EVENT WAS IDENTIFIED ON OCTOBER 17, 2011 AS PART OF A RETROSPECTIVE REVIEW IN REPLY TO THE FDA DETROIT DISTRICT OFFICE, FEI: 3005718816 (26 APR 2011).

    Description of Event or Problem · 1

    THE LPS FLEX PIN GUIDE FOR THE FEMUR WAS PLACED ON THE FEMUR IN SUCH A LOCATION WHERE THE FIT WAS IDEAL AND FLUSH AGAINST THE BONE. AFTER COMPLETION OF THE DISTAL FEMORAL CUT, THE PINS WERE PLACED IN THE SAME DISTAL DRILL HOLES CREATED FROM THE PSI PIN GUIDE. THE 4-IN-1 GOLD FLEX MINI BLOCK WAS PLACED OVER THOSE PINS AND SECURED. THE DRILL HOLES AND PIN POSITION FOR THE 4-IN-1 MINI FLEX GOLD BLOCK WERE SET SO POSTERIOR THAT THE ANTERIOR CUT PRODUCED FROM THE GOLD BLOCK CAUSED THE FEMUR TO NOTCH (3-4MM). THIS WAS DISCOVERED DURING THE SAWING OF THE ANTERIOR CUT THROUGH THE APPROPRIATE CUTTING SLOT ON THE GOLD BLOCK. THE PIN HOLES ON THE PSI PIN GUIDES WERE IN AN INCORRECT LOCATION BASED ON THIS PT'S ANATOMY THUS CAUSING A 3-4MM NOTCH IN THE ANTERIOR ASPECT OF THE FEMUR. THIS WAS NOT REFLECTED NOR WARNED IN THE PLANNING REPORT.

    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 56508215

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR