BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2213156 · Received August 16, 2011

    Report

    Report Number
    1020279-2011-00333
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 16, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE CAUSE FOR THE RETURNED PATELLA COMPONENTS LOOSENING. MACROSCOPIC PHOTO ANALYSIS AND DIMENSIONAL INSPECTION WERE PERFORMED ON THE RETRIEVED PATELLA COMPONENTS. UPON VISUAL EXAMINATION, THE PATELLA COMPONENTS HAVE DEFORMATION ON THE ARTICULATING AND BACKSIDE SURFACES. THE CRITICAL DIMENSIONS OF THE PATELLA COMPONENTS WERE CHECKED AGAINST (B)(4) AND DRAWING # (B)(4) FOR 32MM PATELLA AND AGAINST (B)(4) AND DRAWING # (B)(4) FOR 35 MM PATELLA USING STANDARD OPERATOR SELF-INSPECTION INSTRUMENTS. FOR BOTH THE COMPONENTS HEIGHT AND THICKNESS MEASURED WITHIN SPECIFICATION. THE DIMENSIONS PROFILE AND OVERALL DIAMETERS COULD NOT BE ACCURATELY MEASURED DUE TO THE DEFORMATION PRESENT. BASED ON THE DIMENSIONAL AND VISUAL ANALYSIS THE FACTORS THAT COULD HAVE CONTRIBUTED TO THE PATELLA COMPONENT LOOSENING COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS REPORTED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II GEN II 7.5MM RESUR PAT 35MM JWH SMITH & NEPHEW ORTHOPAEDICS 09HM06682

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R (B)(4) LOT# 09HM12677