BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 3953846 · Received July 23, 2014

    Report

    Report Number
    1644408-2014-00471
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 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 TO REMOVE A KNEE TIBIAL INSERT THAT BROKE AS A RESULT OF PATIENT WEAR AFTER APPROXIMATELY 16 YEARS OF PATIENT USE. THE ORIGINAL SURGERY TOOK PLACE SOMETIME IN 1998; THE EXACT DATE OF ORIGINAL SURGERY COULD NOT BE LOCATED. NO INFORMATION WAS REPORTED WITH THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. 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 WAS NOT CONDUCTED AS NO LOT NUMBER WAS PROVIDED OR COULD BE ESTABLISHED FOR THE PRODUCT. (B)(4). INFORMATION WAS NOT PROVIDED THAT DEFINITIVELY IDENTIFIED THE ROOT CAUSE OR ANY ADDITIONAL REASON FOR THE WEAR OTHER THAN NORMAL USE. THERE IS NO REPORTED INFORMATION THAT INDICATES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THIS PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD A TOTAL KNEE REPLACEMENT DONE IN 1998. THE POST ON THE 4 X 13 POSTERIOR STABILIZED (PS) TIBIAL INSERT BROKE DUE TO PATIENT WEAR. THE SURGEON REMOVED THE OLD INSERT PLUS THE BROKEN PIECES AND REPLACED IT WITH A NEW 4 X 13 PS INSERT. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431997 FOUNDATION KNEE FOUNDATION PS INSERT 13MM CM 4 JWH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R