BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3938109 · Received March 12, 2014

    Report

    Report Number
    3003998208-2014-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K121640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION THAT COULD EXPLAIN THE REPORTED EVENT. 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 AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    GUIDES SEEMED TO FIT WELL, BUT WE HAD ABOUT A 2/3MM LATERAL NOTCH ON THE FEMUR. THE TIBIA HAD TO BE RECUT TWICE TAKING AN EXTRA +4MM. EVAN WITH THE EXTRA 4MM TAKEN, A 10MM ARTICULAR SURFACE WAS STILL A BIT TIGHT. ABOUT 5-10 MINUTES DELAY REPORTED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147291 ZIMMER PATIENT SPECIFIC INSTRUMENT KNEE PROSTHESIS, MBH, JWH MBH MATERIALISE N.V. 00-5970-000-36 56586156

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR