BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY 79MM

    MDR report key: 4306138 · Received December 8, 2014

    Report

    Report Number
    0001825034-2014-08925
    Event Type
    Injury
    Date Received
    December 8, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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: ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08920 / 08925).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO INFECTION. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND A CEMENT SPACER MOLD WAS IMPLANTED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2012 WHERE ALL COMPONENTS WERE REMOVED AND A TOTAL KNEE SYSTEM WAS IMPLANTED. PATIENT UNDERWENT A THIRD REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. DURING THE PROCEDURE, SURGEON HAD DIFFICULTY REMOVING THE TIBIAL OFFSET ADAPTOR AND TIBIAL STEM AS THE STEM HAD BEEN CEMENTED IN. THE COMPONENTS WERE REMOVED AND A 60 MINUTE DELAY OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790433 BIOMET OFFSET TIBIAL TRAY 79MM PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 660110

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R