BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2931613 · Received January 22, 2013

    Report

    Report Number
    1644408-2013-00018
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K905613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS MEDIAL LATERAL INSTABILITY IN THE RIGHT KNEE AFTER THREE MONTHS 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. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE (B)(4) COMPLAINT FOR THIS PART NUMBER: THREE FOR INSTABILITY, TWO FOR LOOSE JOINT, TWO DUE TO THREAD PROBLEMS, ONE LABEL ISSUE, TWO DUE TO PAIN, ONE FOR FIXATION, ONE VALGUS POSITION, ONE VARUS POSITION, AND ONE FOR A PACKAGING ISSUE. THE ROOT CAUSE FOR THE MEDIAL LATERAL INSTABILITY WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN INSTABILITY SUCH AS; TRAUMA, BONE QUALITY DETERIORATION, AND DISEASE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD MEDIA - LATERAL INSTABILITY IN THE RIGHT KNEE. THE SURGEON ELECTED TO REPLACE THE TIBIA IMPLANT, FEMUR IMPLANT, AND TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30076 FOUNDATION KNEE NON-POROUS STEMMED TIBIA JWH ENCORE MEDICAL, L.P. 235B1067

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention (B)(4), LOT 911A1011| (B)(4), LOT 59602088