BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY 67MM

    MDR report key: 2419141 · Received January 18, 2012

    Report

    Report Number
    0001825034-2012-00052
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 20, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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, EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00052 / 00054).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO TIBIAL LOOSENING. ALL TIBIAL COMPONENTS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET OFFSET TIBIAL TRAY 67MM PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 738410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R