BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DKNEE

    MDR report key: 4197789 · Received October 23, 2014

    Report

    Report Number
    1644408-2014-00669
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS SUBSIDENCE OF THE TIBIAL BASEPLATE AFTER 8 YEARS, 10 MONTHS IN VIVO. ASIDE FROM THE BELOW-KNEE AMPUTATION OF THE PATIENT'S OPPOSITE LEG, THERE IS NO INFORMATION ABOUT ANY PATIENT INJURIES, ACTIVITIES OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SERIOUS RISK 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 MADE AVAILABLE TO DJO SURGICAL ON 16 DEC 2014 FOR EXAMINATION UNDER RETURN MATERIAL AUTHORIZATION (RMA) #E914715. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH EITHER OF THE COMPONENTS LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THERE IS ONE PRIOR COMPLAINT AGAINST THE PART NUMBER 335-01-106 TIBIAL BASEPLATE (PC-2012-00761). THE COMPLAINT WAS FOR KNEE PAIN DUE TO A LOOSE TIBIAL BASEPLATE, AND CAN BE CONSIDERED UNRELATED TO THE CURRENT COMPLAINT. VISUAL EXAMINATION OF THE RETURNED PARTS REVEALS NOTHING OUT OF THE ORDINARY. THE POROUS TIBIAL BASEPLATE EXHIBITS EXCELLENT OSSEOINTEGRATION OVER ALMOST THE ENTIRE DISTAL SURFACE, SO LOOSENESS OF THE IMPLANT CAN LIKELY BE RULED OUT AS A CAUSE OF THE SUBSIDENCE. THE TIBIAL INSERT SHOWS DAMAGE TO THE THREE ANTERIOR SNAP FEATURES, PROBABLY DUE TO REMOVAL DURING THE REVISION SURGERY. THE INSERT IS WORN, AS ONE WOULD EXPECT AFTER NEARLY 9 YEARS OF USE. A DEFINITIVE ROOT CAUSE FOR THE SUBSIDENCE WAS NOT REPORTED; BUT THE PATIENT'S WEIGHT MAY HAVE CONTRIBUTED TO THE SUBSIDENCE IF THERE HAD BEEN RECENT WEIGHT GAIN FOLLOWING THE AMPUTATION. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE TIBIAL COMPONENT SUBSIDING WHERE THE PATIENT HAS A BELOW-KNEE AMPUTATION ON THE CONTRALATERAL SIDE. THE SURGEON HAD TO REPLACE THE INSERT AND TIBIA STEM TO FIX THE SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675127 3DKNEE 3D POROUS STEMMED TIBIA 6 LEFT JWH ENCORE MEDICAL, L.P. 005512

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R 391-09-006,LOT 997391