BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 4110171 · Received September 23, 2014

    Report

    Report Number
    1644408-2014-00582
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K932425
    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 THE PATIENT SUFFERED A COLLAPSED TIBIAL PLATEAU AFTER 5.1 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 (B)(4) COMPLAINT AGAINST LOT NUMBER 53982012. A TOTAL OF (B)(4) COMPLAINTS HAVE BEEN SUBMITTED AGAINST PART NUMBER 321-01-108. THIS COMPLAINT IS THE RESULT OF PATIENT BONE QUALITY AND THE REMAINING TWO ARE THE RESULT OF A LOOSE BASEPLATE AND BASEPLATE WITHOUT A SCREW. THE ROOT CAUSE OF THE PATIENT'S COLLAPSED TIBIAL PLATEAU WAS THE RESULT OF POOR BONE QUALITY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - FOR A COLLAPSED TIBIAL PLATEAU DUE TO POOR BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590337 FOUNDATION KNEE FOUNDATION NON-POROUS MODULAR REV STEMMED TIBIA 8 LEFT JWH ENCORE MEDICAL, L.P. 53982012

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 320-15-016,LOT 53781946