BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3886352 · Received April 14, 2014

    Report

    Report Number
    3003998208-2014-00005
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    January 21, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K091263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INFORMATION INDICATES THE ANGEL WING WAS NOT USED TO VERIFY ABSENCE OF NOTCHING AS INDICATED INT HE SURGICAL TECHNIQUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENTS GUIDES. GUIDE FIT AS EXPECTED. AFTER CUTTING THE SURGEON NOTICED A NOTCH OF APPROXIMATELY 5MM IN THE ANTERIOR CUT FOR THE FEMUR. A 15 MINUTE DELAY IN SURGERY TIME WAS REPORTED. NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228116 ZIMMER PATIENT SPECIFIC INSTRUMENT KNEE PROSTHESIS MBH MATERIALISE N.V. 00-5970-000-01 14.123347

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR