BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3001558 · Received March 13, 2013

    Report

    Report Number
    1644408-2013-00148
    Date Received
    March 13, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY INSTABILITY AFTER 5.8 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 SIXTH COMPLAINT FOR THIS PART NUMBER: THREE FOR INSTABILITY, ONE DUE TO TRAUMA, AND ONE FOR WEAR/EXCESSIVE WEAR. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE OF THE INSTABILITY WAS DUE TO THE BROKEN TIBIAL POST. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT'S KNEE WAS UNSTABLE. THE KNEE WAS OPENED AND IT WAS FOUND THAT THE TIBIAL INSERT HAD BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104894 FOUNDATION KNEE PS INSERT 11MM CM JWH ENCORE MEDICAL, L.P. 965341

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention