BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 4170534 · Received October 14, 2014

    Report

    Report Number
    1644408-2014-00645
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ALLEVIATE INSTABILITY IN THE PATIENT'S KNEE AFTER 1 MONTH OF USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. 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 AGAINST LOT NUMBER 59603411. A TOTAL OF FOUR COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER. THIS IS THE FIRST COMPLAINT SUBMITTED FOR INSTABILITY. THE REMAINING COMPLAINTS HAVE RESULTED FROM OTHER ISSUES SUCH AS INFECTIONS, DISLOCATION AND PAIN. NO INFORMATION WAS SUPPLIED THAT INDICATED NATURE OR ROOT CAUSE OF THE INSTABILITY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651100 FOUNDATION KNEE FOUNDATION PS INSERT 13MM CM 2 JWH ENCORE MEDICAL, L.P. 59603411

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention