BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2823622 · Received November 2, 2012

    Report

    Report Number
    1644408-2012-00583
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AN AGENT NOTIFIED DJO SURGICAL OF A PRODUCT COMPLAINT INVOLVING A POSTERIOR STABILIZED INSERT DUE TO MECHANICAL FAILURE, RESULTING IN PAIN AND INSTABILITY. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE IS NO INFORMATION IN THIS COMPLAINT REGARDING PATIENT INJURIES, ACCIDENTS, ACTIVITIES, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THIS FAILURE. 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. THE ROOT CAUSE FOR THE FAILURE CANNOT BE STATED WITH CONFIDENCE BECAUSE THE EXPLANT WAS NOT PROVIDED FOR ANALYSIS AND NO PATIENT INFORMATION WAS PROVIDED. SOME FACTORS THAT MAY CONTRIBUTE TO POST BREAKAGE INCLUDE: OBESITY, REPETITIVE 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 CYCLIC STRESS OF THE IMPLANT, AND TRAUMA. NONE OF THESE FACTORS WERE REPORTED.

    Description of Event or Problem · 1

    REVISION SURGERY - MECHANICAL FAILURE OF THE POSTERIOR STABILIZED TIBIAL INSERT, CAUSING A PAINFUL AND UNSTABLE KNEE. THE INSERT POST BROKE AND COMPLETELY SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE PS INSERT 11MM CM JWH ENCORE MEDICAL, L.P. 54035095

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention