BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2082192 · Received May 9, 2011

    Report

    Report Number
    1020279-2011-00154
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    July 8, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE EVALUATED USING MACROSCOPIC AND STEREOMICROSCOPIC EXAMINATION. THE RETURNED GII TIBIA BASE PLATE AND WEDGE HAD BONE CEMENT WELL BONDED TO THE GRIT BLASTED SURFACE. THE TIBIAL TRAY HAD SCRATCHING ON THE PROXIMAL SURFACE SOME OF WHICH WAS LIKELY DUE TO EXTRACTION. THE DISTAL SURFACE OF THE TRAY HAD GOUGING AND DAMAGE THAT WAS LIKELY CAUSED BY THE USE OF A SAW TO REMOVE THE IMPLANT. THE POLYETHYLENE INSERT HAD PITTING AND SCRATCHING ON THE ARTICULATING SURFACE. THERE WAS SCRATCHING OBSERVED ON BOTH THE INSERT AND THE TIBIAL BASEPLATE. THE EXACT CAUSE OF KNEE PAIN COULD NOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. THE ORIGIN OF THE METALOSIS WAS NOT APPARENT FROM THE IMPLANTS RECEIVED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THERE WAS METALOSIS IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIA BASE JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION 04GM18864

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R PART # 71420766, LOT # 06GM00715