BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 TIBIA AUGMENT 71X15MM RL/LM

    MDR report key: 3110004 · Received May 13, 2013

    Report

    Report Number
    0001825034-2013-01454
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." THIS REPORT IS NUMBER 8 OF 9 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01447 / 01455).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 TO REMOVE COMPONENTS DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211074 BMT 360 TIBIA AUGMENT 71X15MM RL/LM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 505850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R