BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE SYSTEM

    MDR report key: 1080980 · Received July 23, 2008

    Report

    Report Number
    1644408-2008-00225
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE INVESTIGATION IS LIMITED IN SCOPE SINCE THE INSERT WAS NOT RETURNED FOR EXAMINATION. IF THE DEVICE CAN BE SENT BACK AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED. THE ORIGINAL SURGERY WAS IN 2007 AND THE REVISION OPERATION WAS IN 2008. THERE WAS NO INFO IN THIS COMPLAINT ABOUT ANY PT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THE PT WAS FEMALE. DURING THE REVISION OPERATION A 13 MM THICK INSERT WAS USED TO REPLACE THE 11 MM THICK INSERT. THE DHR WAS EXAMINED AND THERE WERE NO NMRS OR OTHER DISCREPANCIES WITH THE PRODUCT LOT. THERE WERE NO OTHER PCRS FOR EITHER THE SAME PRODUCT LOT OR PART NUMBER. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY - PT WAS EXPERIENCING TIGHTENING IN HER LEG. AS A RESULT OF THE TIGHTNESS, PT HAD SCAR TISSUE, SO DR PUT IN A LARGER INSERT AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE SYSTEM TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 468912

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention