BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIAL BEARING 10X79/83

    MDR report key: 3211819 · Received July 8, 2013

    Report

    Report Number
    0001825034-2013-02526
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED (B)(4) 2013, DUE TO STIFFNESS. PATIENT'S POSTERIOR CRUCIATE LIGAMENT WAS RELEASED AND THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309108 VANGUARD CR TIBIAL BEARING 10X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 049360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R