BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 3892259 · Received June 24, 2014

    Report

    Report Number
    1644408-2014-00388
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    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 REPORTED AS A BROKEN INSERT AFTER 11.4 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 AND THE PRODUCT COMPLAINT REPORT HISTORY COULD NOT BE CONDUCTED DUE TO A LOT NUMBER NOT BEING REPORTED. THE ROOT CAUSE FOR THE BROKEN INSERT WAS NOT REPORTED AND COULD NOT BE DETERMINED WITH CONFIDENCE.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE POST BREAKING OFF OF THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368574 FOUNDATION KNEE FOUNDATION PS INSERT 11MM CM 8 JWH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R