BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3050673 · Received April 10, 2013

    Report

    Report Number
    1644408-2013-00204
    Date Received
    April 10, 2013
    Date of Event
    April 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    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 TO ADDRESS INSTABILITY AFTER 5.1 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE WERE NO REPORTS OF ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THE 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 AND 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 SEVENTH COMPLAINT FOR THIS PART NUMBER: TWO DUE TO INFECTION, THREE FOR INSTABILITY, ONE DUE TO WEAR/EXCESSIVE WEAR, AND ONE FOR A MISSING PART. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE INSTABILITY COULD NOT BE DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO INSTABILITY; THE SURGEON PERFORMED A POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153484 FOUNDATION KNEE PRIMARY INSERT 11MM CM JWH ENCORE MEDICAL, L.P. 53850275

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention