BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2073232 · Received April 29, 2011

    Report

    Report Number
    1020279-2011-00145
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED GENESIS II COMPONENTS WERE EXAMINED VISUALLY, DIMENSIONALLY, AND FUNCTIONALLY. THE PURPOSE OF THIS INVESTIGATION WAS TO EXAMINE THE RETURNED COMPONENTS. NO DESTRUCTIVE TESTING WAS CARRIED OUT. THE RETURNED TIBIAL TRAY HAS SCRATCHES ON THE POLISHED SURFACE AND THE GRIT BLASTED SURFACE HAD NO BONE CEMENT ATTACHED TO IT. THE GRIT BLASTED SURFACE HAD REGIONS THAT WERE BURNISHED LIKELY DUE TO THE RELATIVE MOTION BETWEEN THE CEMENT AND TRAY. SURFACE ROUGHNESS MEASUREMENTS ON THE STEM REGION AWAY FROM THE BURNISHING ON THE TIBIAL TRAY GRIT BLAST SURFACE WERE PERFORMED UTILIZING A SURFACE PROFILOMETER. THE ROUGHNESS MEASUREMENTS WERE WITHIN SPECIFICATION. THE TIBIAL TRAY STEM REGION HAS WORN OUT AREA ON THE TAPER REGION LIKELY OCCURRED DUE TO RUBBING AGAINST BONE AFTER LOOSENING. THE POLYETHYLENE INSERT HAS PITTING ON THE ARTICULATING SURFACES LIKELY CAUSED DUE TO BONE CEMENT DEBRIS FROM THE LOOSE TIBIAL TRAY. THE INSERT HAS BURNISHED ON THE ARTICULATING SURFACE AND BACKSIDE FROM USAGE. THE OXINIUM FEMORAL COMPONENT HAS SCRATCHES ON THE POSTERIOR CONDYLES LIKELY OCCURRED EITHER DURING INSERTION/EXTRACTION. THE OXINIUM FEMORAL COMPONENT HAS BONE CEMENT WELL BONDED TO THE GRIT BLASTED SURFACE. THE BONE AND BONE CEMENT ATTACHED TO THE RETURNED COMPONENT HAS DARKENED REGIONS INDICATING METALLOSIS. SEM/EDXA WAS CONDUCTED ON A SMALL BONE CHIP WITH DARKENED AREAS FROM THE FEMORAL COMPONENT. TO ENABLE SEM IMAGING OF NONCONDUCTIVE BONE MATERIAL, THE BONE CHIP WAS SPUTTER COATED WITH GOLD. EDXA ANALYSES SHOWED PRESENCE OF CALCIUM BUT NO METAL TRACES WERE DETECTED. THE TIBIAL TRAY GRIT BLAST SURFACE HAS NO BONE CEMENT ATTACHED AND THE SURFACE APPEARED BURNISHED WHICH BOTH INDICATE LOOSENING OF THE TIBIAL TRAY COMPONENT. LABORATORY TESTS HAVE SHOWN THAT CEMENT PREPARATION, CEMENT SURFACE CONTAMINATION, AND SURFACE ROUGHNESS CAN HAVE AN EFFECT ON CEMENT ADHESION. THE FEMORAL COMPONENT APPEARED WELL FIXED AND THE TIBIAL TRAY STEM HAS WORN REGION DUE TO CONTACT WITH THE BONE AFTER LOOSENING. HOWEVER, THE EXACT REASONS FOR METALLOSIS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II FEMORAL JWH SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R PART # 71420188, LOT # UNK| (B)(4)| (B)(4)| PART # 71420778, LOT # UNK