BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3167831 · Received June 11, 2013

    Report

    Report Number
    3005718816-2013-00004
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K121640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION 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

    IT WAS REPORTED A TOTAL KNEE REPLACEMENT WAS PERFORMED GUIDED BY THE DEVICE. THE PHYSICIAN REPORTED THE FIT OF THE DEVICE WAS VERY WELL. AFTER PERFORMING THE ANTERIOR FEMORAL CUT A SIGNIFICANT NOTCH WAS OBSERVED. NO OTHER ADVERSE EFFECTS, SIGNIFICANT BLOOD LOSS OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264797 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-25 56560473

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR