BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3052320 · Received April 11, 2013

    Report

    Report Number
    1644408-2013-00209
    Date Received
    April 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY ON (B)(6) 2003 WAS DUE TO THE POSTERIOR STABILIZED (PS) POST BREAKING. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED. 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 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 FIRST COMPLAINT AGAINST THIS PART NUMBER. THE ROOT CAUSE OF THE POST BREAKING CANNOT BE DETERMINED WITH CONFIDENCE. SOME FACTORS THAT CAN CONTRIBUTE TO THE POST BREAKAGE ARE: EXCESSIVE FULL FLEXURE CYCLES, EXTREME KNEE ARTICULATION (EXTERNAL AND INTERNAL ROTATION COMBINED WITH FULL FLEXURE), LIFTING OR MOVING HEAVY OBJECTS, HIGH ACTIVITY LEVELS LEADING TO WEAR AND STRESS OF THE IMPLANT, TRAUMA, AND IMPLANT POSITIONING. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DURING THE LEFT KNEE REVISION SURGERY, THE POSTERIOR STABILIZED (PS) POST BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155967 FOUNDATION KNEE P.S. INSERT, SIZE 8, 11MM JWH ENCORE MEDICAL, L.P. 754681

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention