BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2571439 · Received May 7, 2012

    Report

    Report Number
    3003998208-2012-00009
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    February 29, 2012
    Report Date
    September 4, 2012
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION CONFIRMS THE UTILIZED PT SPECIFIC INSTRUMENTS MET THE SPECIFICATIONS AND THE PLANNING REVIEWED AND APPROVED BY THE SURGEON. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE INITIAL REPORTER SUGGESTED THE UNCOMMON HARDNESS OF THE BONE MIGHT HAVE BEEN A CONTRIBUTING FACTOR. THE MANUFACTURER IS PURSUING MORE INFO FROM THE INITIAL REPORTER TO BE ABLE TO CONFIRM OR EXCLUDE THIS OPTION. SHOULD ADDITIONAL INFO BECOME AVAILABLE THAT CHANGES THE CURRENT 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. TWO SCREWS WERE USED TO FIX THE ANTERIOR AREA. THIS RESULTED IN AN ADDITIONAL 30 MINUTES IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE N.V. 00-5970-000-01 26527083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening