BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIETN SPECIFIC INSTRUMENT

    MDR report key: 2688038 · Received August 6, 2012

    Report

    Report Number
    3005718816-2012-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    May 16, 2012
    Report Date
    July 9, 2012
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NARRATIVE OF THE EVENT PROVIDED BY THE COMPLAINANT SHOWS THE PROVIDED SURGICAL TECHNIQUE WAS NOT FOLLOWED COMPLETELY. IN PARTICULAR, A DESCRIBED STEP TO VERIFY THE ABSENCE OF NOTCHING WAS SKIPPED. THEREFORE, A FAILURE TO FOLLOW THE INSTRUCTIONS IS CONSIDERED PART OF THE INVESTIGATION CONCLUSION. THE RETURNED DEVICE WAS EVALUATED. THIS SHOWS THE PRODUCED DEVICE MET THE DESIGN SPECIFICATIONS AND WAS NOT DEFORMED DURING USE. AN EVALUATION OF THE PT SPECIFIC DESIGN SPECIFICATIONS IS IN PROGRESS. AN ADDITIONAL REPORT WILL BE SUBMITTED AFTER COMPLETION OF THIS EVALUATION.

    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 OF 3 MM IN THE ANTERIOR CUT FOR THE FEMUR WAS NOTICED DURING SURGERY AFTER THE CUT WAS PERFORMED. A NOTCH VERIFICATION USING AN ANGEL WING CHECK WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIETN SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-01 56531252

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR