BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 3214088 · Received July 3, 2013

    Report

    Report Number
    1644408-2013-00352
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ADDRESS A BROKEN INSERT AFTER 13.6 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED AS SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 DEVICE WAS DISPOSED OF BY THE HOSPITAL 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: THREE DUE TO WEAR/EXCESSIVE WEAR, THREE FOR A CRACKED/BROKEN DEVICE, AND ONE FOR STABILITY/POOR JOINT ISSUES. THIS IS THE THIRD COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION SURGERY WAS MOST LIKELY DUE TO WEAR. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - BROKEN POST ON A SIZE 4X9 POSTERIOR STABILIZED TIBIAL INSERT DUE TO PT'S WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303919 FOUNDATION KNEE INSERT, PS 9MM SZ4 JWH ENCORE MEDICAL, L.P. 162891

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention