BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1971503 · Received January 27, 2011

    Report

    Report Number
    8010764-2011-00004
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    March 31, 2011
    Manufacturer
    SMITH & NEPHEW, INC., GERMANY MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS.

    Additional Manufacturer Narrative · 1

    MACROSCOPIC PHOTO ANALYSIS AND PROFILOMETRY WERE PERFORMED ON THE RETRIEVED IMPLANTS. UPON VISUAL EXAMINATION, SCRATCHES CAUSED BY INSTRUMENTS AND/OR THIRD BODIES WERE OBSERVED ON THE PROXIMAL SURFACE. MINIMAL BONE CEMENT WAS OBSERVED IN THE FIXATION AREA. BURNISHING OF THE RIDGE AROUND THE PERIPHERY WAS OBSERVED INDICATING RELATIVE MOTION BETWEEN THE TIBIAL BASE AND THE BONE CEMENT. THE ROUGHNESS OF THE DISTAL FIXATION AREA OF THE TIBIAL BASE WAS MEASURED USING A CONTACT PROFILOMETER. THE MEAN ROUGHNESS WAS FOUND TO BE WITHIN SPECIFICATION. BURNISHING, ABRASIVE WEAR AND INDENTATIONS WERE OBSERVED IN THE PROXIMAL ARTICULATING AREAS OF THE INSERT. THE MEDIAL ARTICULAR AREA WAS LOCATED MORE ANTERIORLY THAN THAT IS TYPICALLY SEEN IN OTHER RETRIEVED INSERTS SUGGESTING THAT A COMBINATION OF INTERNAL ROTATION OF THE INSERT AND/OR EXTERNAL ROTATION OF THE FEMORAL COMPONENT MAY HAVE OCCURRED. MILD ROUNDING TYPICALLY SEEN IN A FULLY LOCKED INSERT WAS OBSERVED ON ONE SIDE OF THE ANTERIOR LOCKING MECHANISM WHEREAS DAMAGE CAUSED BY INSTRUMENTS WAS OBSERVED ON THE OTHER SIDE. MILD IMPINGEMENT WAS OBSERVED NEAR THE ANTEROLATERAL PART OF THE POST. BURNISHING WAS OBSERVED ON THE DISTAL ARTICULATING SURFACE. BURNISHING AND DEFORMATION DUE TO CONTACT WITH FEMORAL CAM WAS OBSERVED IN THE POSTEROMEDIAL PART OF THE POST. IN CONCLUSION, THE TIBIAL BASE SHOWED SIGNS OF LOOSENING. THE PRESENCE OF THIRD BODY PARTICLES, LIKELY BONE CEMENT GENERATED FROM TIBIAL BASE LOOSENING, IN THE ARTICULATING AREAS CAUSED THE ABRASIVE WEAR AND INDENTATIONS OBSERVED ON THE TIBIAL INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIAL BASEPLATE JWH SMITH & NEPHEW, INC., GERMANY MANUFACTURING SITE 10CT40191

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PRODUCT NUMBER: 71421515, LOT NUMBER: 09HM16122