BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII

    MDR report key: 1862670 · Received October 8, 2010

    Report

    Report Number
    1020279-2010-00286
    Event Type
    Injury
    Date Received
    October 8, 2010
    Report Date
    October 15, 2010
    Manufacturer
    SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THE INVESTIGATION WAS TO PERFORM ANALYSIS OF THE RETRIEVED FEMORAL COMPONENT, INSERT AND TIBIAL BASE. MACROSCOPIC PHOTO ANALYSIS, DIMENSIONAL INSPECTION, AND STEREOMICROSCOPY AND SCANNING ELECTRON MICROSCOPY WITH ENERGY DISPERSIVE X-RAY ANALYSIS WERE PERFORMED ON THE RETRIEVED IMPLANTS. BONE AND BONE CEMENT DEBRIS WERE OBSERVED IN THE FIXATION AREA OF THE FEMORAL COMPONENT. THE APPEARANCE OF THE CEMENT MANTLE INDICATES THE FEMORAL COMPONENT WAS LIKELY WELL FIXED TO THE HOST BONE. SCRATCHES CAUSED BY INSTRUMENTS WERE OBSERVED IN THE PATELLAR GROOVE AND ON THE MEDIAL CONDYLE. SCRATCHES WERE ALSO OBSERVED ON THE POSTERIOR CONDYLES. EDXA ANALYSIS OF THESE SCRATCHES REVEALED THE PRESENCE OF TI, AL, AND V INDICATING THAT THE FEMORAL COMPONENT CAME INTO CONTACT WITH THE TIBIAL BASE. UPON VISUAL EXAMINATION OF THE TIBIAL BASE, SCRATCHES CAUSED BY INSTRUMENTS WERE OBSERVED ON PROXIMAL SURFACES. NO BONE CEMENT DEBRIS WAS OBSERVED IN THE FIXATION AREA. DAMAGE AND SCRATCHES WERE OBSERVED NEAR THE ANTERIOR AND MEDIAL PERIPHERY ON THE DISTAL SIDE THAT MAY HAVE CAUSED BY INSTRUMENTS DURING EXTRACTION OF THE TIBIAL BASE. BURNISHING DUE TO MICROMOTION WAS OBSERVED IN THE FIXATION AREA INDICATING A DEGREE OF LOOSENING OF THE BASE RELATIVE TO THE HOST BONE. UPON VISUAL EXAMINATION OF THE TIBIAL INSERT, BURNISHING, ABRASIVE WEAR AND INDENTATIONS WERE OBSERVED THROUGHOUT THE PROXIMAL ARTICULATING SURFACE. THE INDENTATIONS AND ABRASIVE WEAR WERE SIMILAR IN APPEARANCE TO THOSE SEEN ON PREVIOUS RETRIEVALS THAT WERE CAUSED BY BONE AND/OR BONE CEMENT DEBRIS. X-RAY ANALYSIS DID NOT FIND ANY BONE AND/OR BONE CEMENT DEBRIS IN THE ARTICULATING AREAS. MILD ROUNDING THAT IS TYPICALLY SEEN IN A LOCKED INSERT WAS OBSERVED NEAR THE ANTERIOR LOCKING MECHANISM. DAMAGE CAUSED BY INSTRUMENTS DURING IMPLANTATION OR EXTRACTION WAS OBSERVED NEAR THE ANTERIOR LOCKING MECHANISM, AND ON THE DISTAL SURFACE. DOWNWARD DEFORMATION OF THE OUTER SIDES OF THE DOVETAILS THAT MAY HAVE OCCURRED DURING EXTRACTION OF THE IMPLANT WAS ALSO OBSERVED. IN CONCLUSION, THE FEMORAL COMPONENT APPEARED TO BE WELL FIXED. THE BURNISHING SEEN IN THE FIXATION AREA OF THE TIBIAL BASE INDICATES A DEGREE OF LOOSENING. THE INDENTATIONS AND ABRASIVE WEAR PATTERNS OBSERVED ON THE RETRIEVED INSERT LIKELY RESULTED FROM THIRD BODY DEBRIS SUCH AS BONE AND/OR BONE CEMENT, HOWEVER NO SUCH DEBRIS WAS FOUND ON THE ARTICULATING SURFACE.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM INFECTION LIKE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GII INSERT HRY SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE 07GM10902

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R