BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2329641 · Received October 21, 2011

    Report

    Report Number
    3003998208-2011-00006
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, IT SUGGESTS THE NOTCH WAS CAUSED BY PLACING THE GUIDE TOO POSTERIORLY, CAUSING THE ANTERIOR AND POSTERIOR CUT TO BE MORE POSTERIOR THAN PLANNED. 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 (B)(4).

    Description of Event or Problem · 1

    THE ANTERIOR CUT TO PLACE THE FEMORAL IMPLANT, WAS PERFORMED WITH A CUT BLOCK WHICH WAS GUIDED BY THE DEVICE. A NOTCH WAS NOTICED DURING SURGERY AFTER THE CUT WAS PERFORMED. A CORRECTION WAS PERFORMED USING TRADITIONAL INSTRUMENTATION.

    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 56502138

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR