BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INTERLOK 79MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

    MDR report key: 2001744 · Received February 25, 2011

    Report

    Report Number
    1825034-2011-00131
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: UNDER WARNINGS, NUMBER THREE STATES,"THE LOCKING BAR USED TO SECURE THE TIBIAL PLATE AND TIBIAL-BEARING COMPONENTS TOGETHER MUST LOCK SECURELY INTO PLACE WITH AN AUDIBLE CLICK AT THE TIME OF IMPLANTATION." OTHER - LOCKING BAR WAS ASSEMBLED TO A TRAY WITH THE LOCKING TABS CUT AWAY SO THAT LOCKING BAR TRAVEL AND ENGAGEMENT COULD BE OBSERVED. THE LOCKING BAR FUNCTIONED FULLY WITH COMPLETE ENGAGEMENT INCLUDING CLEARANCE BEHIND THE LOCKING BAR TIP. BASED ON DIMENSIONAL, VISUAL, AND ASSEMBLY EVALUATION THE LOCKING BAR MEETS BIOMET SPECIFICATIONS AND PERFORMS AS INTENDED. THERE WERE NO OUT OF SPECIFICATION DIMENSIONS THAT WOULD RELATE TO THE COMPONENT NOT SEATING OR COMING LOOSE. IT MAY BE POSSIBLE THAT THE LOCKING BAR WAS NOT FULLY SEATED AT THE TIME OF IMPLANTATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. 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. (B)(4).

    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) 2011, DUE TO THE LOCKING BAR BACKING OUT. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INTERLOK 79MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 963600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R