BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR POR FMRL-LT 60

    MDR report key: 3120829 · Received May 20, 2013

    Report

    Report Number
    0001825034-2013-01570
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK033489
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 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 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01568 / 01571).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. ALL BIOMET PRODUCT WAS REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222808 VANGUARD CR POR FMRL-LT 60 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 329320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R