BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2717754 · Received August 23, 2012

    Report

    Report Number
    1644408-2012-00445
    Event Type
    Other
    Date Received
    August 23, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    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

    ON (B)(6), 2012 AN AGENT INFORMED DJO SURGICAL THAT A REVISION SURGERY INVOLVING THE REPLACEMENT OF A CONSTRAINED SIZE 6X15MM TIBIAL INSERT WAS PERFORMED. THE DESCRIPTION OF THE EVENT INDICATES THAT THE PRIMARY REASON FOR THE REVISION SURGERY WAS A BROKEN POST DUE TO WEAR. THIS DEVICE WAS IN USE FOR 12.9 YEARS. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE TIBIAL INSERT POST FRACTURE. 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. (B)(4). A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS ONE PRIOR COMPLAINT FOR THIS LOT NUMBER INVOLVING THE SAME FAILURE MODE. THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE BECAUSE THE DEVICES WERE NOT RETURNED TO DJO SURGICAL FOR EVALUATION. THERE ARE NO INDICATIONS OF A MANUFACTURING OR DESIGN PROBLEM WHICH WOULD HAVE CAUSED THE EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY- THE PATIENT HAD A BROKEN POST ON SIZE 6X15 POSTERIOR STABILIZED TIBIAL INSERT, DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE POSTERIOR STABILIZED TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 237151

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention