BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 3932319 · Received July 14, 2014

    Report

    Report Number
    1644408-2014-00444
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REPLACE THE PATIENTS LOOSE PROSTHESIS AFTER 1.8 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED 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 FROM THIS LOT. THE ROOT CAUSE FOR THE PATIENTS LOOSE PROSTHESIS WAS REPORTED TO BE THE PATIENT HYPER EXTENDING THEIR KNEE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE IMPLANTS LOOSENED UP DUE TO THE PATIENT HYPEREXTENDING THEIR KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411231 FOUNDATION KNEE FOUNDATION ULTRA-CONGRUENT INSERT 11MM CM 4 JWH ENCORE MEDICAL, L.P. 59602557

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention 201-01-104, LOT 711A1044