BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INTERLOK 75MM FIXED CRUCIATE TIBIAL PLATE W/ LOCKING BAR

    MDR report key: 1875190 · Received October 19, 2010

    Report

    Report Number
    1825034-2010-00440
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY.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 OF THE RETURNED DEVICE FOUND EVIDENCE TO SUGGEST THAT THERE WERE NO MANUFACTURING NON-CONFORMANCE. THE REPORTED EVENT OF LOOSENING IS BELIEVED TO BE THE RESULT OF A TECHNIQUE RELATED ISSUE. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND WAS REVISED ON AN UNKNOWN DATE DUE TO LOOSENING OF THE TIBIAL TRAY. THE TIBIAL TRAY WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND WAS REVISED ON AN UNKNOWN DATE, DUE TO LOOSENING OF THE TIBIAL TRAY. THE TIBIAL TRAY WAS REMOVED AND REPLACED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INTERLOK 75MM FIXED CRUCIATE TIBIAL PLATE W/ LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 994160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R