BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIK KNEE

    MDR report key: 2945070 · Received January 31, 2013

    Report

    Report Number
    1644408-2013-00051
    Event Type
    Other
    Date Received
    January 31, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HRY
    PMA / PMN Number
    K020741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2004 AND THE REVISION ON (B)(6) 2003. THE COMPONENTS HAD BEEN IN-VIVO APPROXIMATELY NINE YEARS AND SEVEN MONTHS AT THE TIME OF REVISION. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE IS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT PATIENT ACTIVITY LEVEL, HISTORY OF TRAUMA, AND GENERAL HEALTH CONDITION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. TWO COMPONENTS; UNI FEMUR KNEE AND POLY INLAY WERE RETURNED TO DJO SURGICAL FOR EXAMINATION. REMNANTS OF CEMENT ARE VISIBLE ON THE BACKSIDE OF THE FEMORAL COMPONENT AND ON THE SIDES AND BACKSIDE OF THE POLY INLAY. THE ARTICULATING SURFACE HAS SUBSTANTIAL WEAR AND SIGNS OF DELAMINATION TOWARDS THE MEDIAL SIDE. SOME DAMAGE MAY BE DUE TO EXTRACTION DURING REVISION. WHEN THE FEMORAL CONDYLE IS PLACED ON THE INLAY AND RESTS IN THE WORN GROOVE IT APPEARS TO BE MISALIGNED AND SHIFTED MEDIALLY. IT CANNOT BE DETERMINED, WITHOUT POST OP X-RAYS, IF THE COMPONENTS WERE IMPLANTED IN THIS POSITION OR IF THE INLAY SHIFTED DUE TO WEAR, BONE LOSS, LOSS OF FIXATION, OR SOME OTHER REASON. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THE ROOT CAUSE FOR THE REVISION SURGERY WAS STABILITY ISSUES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; FACTORS THAT CAN CONTRIBUTE TO LOSS OF STABILITY INCLUDE: LOSS OF SOFT TISSUE TENSION, COMPONENT POSITIONING OR SHIFTING IN-VIVO, BONE LOSS, BONE DISEASE, TRAUMA, AND CEMENT MANTLE LOOSENING. THERE IS NO EVIDENCE OF A DESIGN OR MANUFACTURING PROBLEM THAT CONTRIBUTED TO THIS COMPLAINT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON REMOVED THE FEMUR AND TIBIA OF THE UNI COMPARTMENTAL KNEE. THE AGENT WAS NOT ABLE TO DETERMINE THE PART AND LOT NUMBERS DUE TO BOTH BEING COVERED IN CEMENT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO STABILITY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42289 EPIK KNEE UNI FEMUR HRY ENCORE MEDICAL, L.P. 887291

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention