BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL LOCKING BAR

    MDR report key: 1894427 · Received November 9, 2010

    Report

    Report Number
    1825034-2010-00514
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    July 23, 2008
    Report Date
    October 11, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. (B)(4).

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. 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. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2002 AT ANOTHER FACILITY. SUBSEQUENTLY, HIS KNEE GAVE OUT AND HE WAS REVISED ON (B)(6), 2008 TO REMOVE AND REPLACE THE LOCKING BAR. PATIENT FURTHER REPORTED THAT HE FELL AND DEVELOPED AN INFECTION. ANOTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2008 TO REMOVE AND REPLACE ALL KNEE COMPONENTS WITH CEMENT SPACER MOLDS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A KNEE REVISION PROCEDURE ON (B)(6) 2008 TO REMOVE AND REPLACE LOCKING BAR. SUBSEQUENTLY, PATIENT REPORTED THAT HE FELL AND DEVELOPED AN INFECTION. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 TO REMOVE AND REPLACE ALL KNEE COMPONENTS WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MODULAR TIBIAL LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 790650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R