BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2931644 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00045
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    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 ADDRESS WEAR OF THE PATIENT'S PROSTHETICS AFTER (B)(6) YEARS OF PATIENT USE. 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 IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. 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. (B)(4). THE ROOT CAUSE FOR THE REVISION WAS DUE TO NORMAL WEAR. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THIS REVISION COVERS THE RIGHT KNEE; THE LEFT KNEE IS REFERENCED IN (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD BILATERAL ENCORE FOUNDATION KNEES PUT IT ON THE (B)(6) 1998. THE SURGEON REVISED BOTH KNEES INSERTS DUE TO NORMAL WEAR. THE PATIENT HAD 6X9 POSTERIOR STABILIZED TIBIAL INSERTS ON BOTH SIDES; ONE REPLACED WITH SAME SIZE THE OTHER REPLACED WITH 6X11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34049 FOUNDATION KNEE POSTERIOR STABILIZED TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 270311

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention