BEUDAMED
    FDA Adverse Event Summary report: N

    3DKNEE

    MDR report key: 2992785 · Received March 7, 2013

    Report

    Report Number
    1644408-2013-00128
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ADDRESS SCAR TISSUE AFTER 2 YEARS, 4 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED 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 SHOWS THIS IS THE (B)(4) COMPLAINT FOR THIS PART NUMBER: (B)(4) DUE TO INSTABILITY, (B)(4) DUE TO PAIN, (B)(4) DUE TO INFECTION, AND (B)(4) FOR DAMAGED THREADS. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION SURGERY WAS DUE TO SCAR TISSUE; THE CAUSE FOR THE SCAR TISSUE IS NOT DETERMINED. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROCESS DEFECT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON PERFORMED A POLY SWAP DUE TO THE PATIENT DEVELOPING SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97332 3DKNEE DCM INSERT, 9MM SIZE 5 JWH ENCORE MEDICAL, L.P. 54009939

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention