BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DKNEE

    MDR report key: 3870030 · Received June 12, 2014

    Report

    Report Number
    1644408-2014-00361
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 5.1 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR REVISION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE THIRD COMPLAINT FOR A PART FROM THIS LOT. THE ROOT CAUSE FOR THE INSTABILITY WAS REPORTEDLY DUE TO THE PATIENTS JOINT BEING TIGHT . THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT'S KNEE BEING TIGHT; THE SURGEON NEEDED TO GO TO A SMALLER INSERT SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347753 3DKNEE 3D DCM INSERT, 13MM 8 LEFT JWH ENCORE MEDICAL, L.P. 450872

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention