BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL 65MM LEFT INTERLOK

    MDR report key: 1912914 · Received December 2, 2010

    Report

    Report Number
    1825034-2010-00634
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND RESIDUAL BONE AND BONE CEMENT. THE ARTICULATING SURFACE HAS SOME CONDYLE WEAR MARKS. THERE ARE NO MAJOR WEAR AREAS, SCRATCHES OR GOUGES. THIS REPORT FILED (B)(6), 2011.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: POSSIBLE ADVERSE EFFECT #1 - MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES CAN RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS. THE CLINICAL SIGNIFICANCE OF THIS EFFECT IS UNCERTAIN, AS SIMILAR CHANGES MAY OCCUR AS A PRECURSOR TO OR DURING THE HEALING PROCESS. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON NOVEMBER 30, 2010. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT NECESSARY BASED ON THE EVENT BEING REPORTED. INFORMATION RELAYED IN THE ATTACHED USER FACILITY REPORT INDICATES THE PATIENT'S KNEE FUNCTIONED WELL, BUT SHE HAD RECURRENT EFFUSION AND ALLERGY TESTING SHOWED HIGH POSITIVE CORRELATION WITH NICKEL. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO RECURRENT EFFUSION AND METAL ALLERGY. THE FEMORAL COMPONENT, TIBIAL PLATE AND TIBIAL BEARING WERE ALL REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO RECURRENT EFFUSION AND METAL ALLERGY. THE FEMORAL COMPONENT, TIBIAL PLATE AND TIBIAL BEARING WERE ALL REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO RECURRENT EFFUSION AND METAL ALLERGY. THE FEMORAL COMPONENT, TIBIAL PLATE AND TIBIAL BEARING WERE ALL REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO RECURRENT EFFUSION AND METAL ALLERGY. THE FEMORAL COMPONENT, TIBIAL PLATE AND TIBIAL BEARING WERE ALL REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD CR FEMORAL 65MM LEFT INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 285080

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R