BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INTERLOK 71MM FIXED I-BEAM TIBIAL PLATE W/ LOCKING BAR

    MDR report key: 2173866 · Received July 24, 2011

    Report

    Report Number
    1825034-2011-00600
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(4), 2011 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND USER FACILITY REPORT NUMBER REFERENCED IN THIS MEDWATCH ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. THIS REPORT FILED (B)(4), 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: "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." EVALUATION CONSISTED OF THE RETURNED LOCKING BAR COMPONENT ONLY, AS THE TIBIAL PLATE REMAINS IMPLANTED. EVALUATION OF THE RETURNED COMPONENT FOUND THE ARM TIP TO BE FRACTURED. THE ARM TIP HAS LONGITUDINAL ABRASIONS AND THE TIP IS ABRADED. THE BAR TIP HAS SCRATCHES, ABRASIONS AND BURNISHING. THE FRACTURE SURFACE HAS NEAR PARALLEL LINES PERPENDICULAR TO THE BAR AXIS. THE INSIDE CORNER OF THE SURFACE HAS A PATTERN OF WEAR THAT SUGGESTS ABRASION, WHICH LIKELY OCCURRED POST FRACTURE. THE TIP FRACTURE SURFACE HAS DEFORMATION AT THE LOWER LEFT CORNER WHERE THE LOAD WAS APPLIED TO THE BAR. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 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. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011DUE TO FRACTURE OF THE LOCKING BAR. THE LOCKING BAR WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INTERLOK 71MM FIXED I-BEAM TIBIAL PLATE W/ LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 566000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R