BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT PACIFIC INSTRUMENT

    MDR report key: 2329662 · Received October 21, 2011

    Report

    Report Number
    3003998208-2011-00005
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    March 30, 2010
    Report Date
    April 6, 2010
    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

    A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, IT SUGGESTS THE NOTCH WAS CAUSED BY PLACING THE GUIDE TOO PROXIMALLY DUE TO A SMOOTH ANTERIOR SURFACE, CAUSING THE DISTAL CUT TO BE MORE IN EXTENSION THAN PLANNED. SHOULD ADD'L INFO BECOME AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THIS REPORTABLE EVENT WAS IDENTIFIED ON OCTOBER 17, 2011 AS PART OF A RETROSPECTIVE REVIEW IN REPLY TO THE FDA (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON NOTICED THE FEMUR ANTERIOR CUT NOTCHED. THIS WAS CORRECTED BY SWITCHING TO TRADITIONAL INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT PACIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-01 56.502.307

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR