BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3603464 · Received December 3, 2013

    Report

    Report Number
    3005718816-2013-00010
    Event Type
    Malfunction
    Date Received
    December 3, 2013
    Date of Event
    September 5, 2013
    Report Date
    November 4, 2013
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K091263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. THE PRE-OPERATIVE PLAN WAS REVIEWED AND APPROVED BY THE PHYSICIAN. THE RECEIVED INFO INDICATES THE ANGEL WING WAS NOT USED TO VERIFY ABSENCE OF NOTCHING AS INDICATED IN THE SURGICAL TECHNIQUE. A DEFINITIVE 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 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. THE FEMUR IMPLANT IS PLACED IN EXTENSION. THE REPORTER REPORTED A GOOD FIT OF THE GUIDE. NO BLOOD LOSS, DELAY DURING SURGERY OR OTHER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626152 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-01 5655399

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR