BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DKNEE

    MDR report key: 3851146 · Received June 5, 2014

    Report

    Report Number
    1644408-2014-00340
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 3.25 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 FIRST COMPLAINT FOR THIS LOT. THE ROOT CAUSE FOR THE INSTABILITY WAS MOST LIKELY THE PATIENT'S FLEXION CONTRACTURE AS REPORTED. 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 HAVING A FLEXION CONTRACTURE AND NOT GETTING FULL EXTENSION. THE STANDARD PROTOCOL IS FOR THE SURGEON TO GO IN AND RELEASE TISSUE; THE SURGEON DECIDED TO SWAP THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329658 3DKNEE 3D DCM INSERT, 9MM 10 RIGHT JWH ENCORE MEDICAL, L.P. 53949302

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention