BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3111262 · Received May 8, 2013

    Report

    Report Number
    3003998208-2013-00004
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K091263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INFO 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

    THE PT WAS SCHEDULED TO UNDERGO A TOTAL KNEE REPLACEMENT GUIDED BY THE DEVICE. AFTER PLACEMENT OF THE FEMORAL DISTAL PINS, THE PHYSICIAN WAS NOT SATISFIED WITH THE LOCATION AND CORRECTED THIS USING TRADITIONAL INSTRUMENTATION. THIS RESULTED IN A DELAY OF 30 MINUTES. NO OTHER INJURY OR SIGNIFICANT BLOOD LOSS WAS REPORTED. THE REPORTER INCLUDED THE PT IS DOING FINE POSTOPERATIVELY WITH FULL EXTENSION AND FLEXION OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202396 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE N.V. 00-5970-000-01 13.848.030

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other