BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR MONO-LOCK BEARING 14X79

    MDR report key: 3203797 · Received July 3, 2013

    Report

    Report Number
    0001825034-2013-02464
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    March 27, 2009
    Report Date
    June 6, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK060525
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 (B)(4). THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02463 / 02464).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY, UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008, AND A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION OF BOTH KNEES (B)(6) 2009 DUE TO INFECTION. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND BEARINGS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304521 VANGUARD CR MONO-LOCK BEARING 14X79 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 110590

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R