BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1930410 · Received December 16, 2010

    Report

    Report Number
    1020279-2010-00359
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    April 29, 2011
    Manufacturer
    SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL AND FOLLOW-UP MDRS WERE MISTAKENLY FILED UNDER MANUFACTURER # 1020279. THE CORRECT MANUFACTURER # IS 8010764.

    Additional Manufacturer Narrative · 1

    EXAMINATION METHODS: STEREOMICROSCOPE, SCANNING ELECTRON MICROSCOPY (SEM), ENERGY DISPERSIVE X-RAY ANALYSIS (EDXA). MACROSCOPIC EXAMINATION OF THE DEVICES SHOWED: AS RECEIVED COMPONENT, NO VISIBLE BONE CEMENT OR BURNISHING ON GRIT BLASTED SURFACE OF BASE PLATE, ABRASIVE WEAR ON PROXIMAL FACE OF TIBIAL TRAY, MILD BURNISHING. MATERIAL ANALYSIS (EDXA) SHOWED THAT: NO CHEMICAL ANOMALIES WERE SEEN WHEN COMPARED TO A STANDARD OF THE MATERIAL THEREFORE THERE WERE NO MATERIAL DEVIATIONS WERE FOUND IN THIS INVESTIGATION THE GRIT BLASTED SURFACE OF THE TRAY WAS FOUND TO HAVE SURFACE ROUGHNESS THAT MET SPECIFICATION. MILD BURNISHING WAS OBSERVED IN THE PROXIMAL ARTICULATING AREAS OF THE INSERT. THERE WAS NO VISIBLE BONE CEMENT OR BURNISHING ON THE GRIT BLASTED SURFACE OF BASE PLATE. POSSIBLE CAUSES OF LACK OF BONE CEMENT ADHERING TO THE IMPLANT INCLUDE BUT ARE NOT LIMITED TO: MOISTURE BETWEEN BONE CEMENT AND IMPLANT SURFACE AND EXCEEDING WORKING TIME OF BONE CEMENT. THE EXACT CAUSE OF TRAY LOOSENING COULD NOT BE ASCERTAINED FROM THE INFORMATION PROVIDED.

    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., BROOKS MANUFACTURING SITE 09BT28768

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R PRODUCT NUMBER: 71420846, LOT NUMBER: NI