BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY 79MM

    MDR report key: 2621118 · Received June 19, 2012

    Report

    Report Number
    0001825034-2012-00866
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 24, 2012
    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION". REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 5 OF 10 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00862 / 00871).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6), 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2012, DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC CEMENT SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET OFFSET TIBIAL TRAY 79MM PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 022590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R