BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD ANT STBLZD BRG 16X71

    MDR report key: 2992026 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00498
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK050222
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 WARNINGS IT STATES, "EXCESSIVE ACTIVITY, TRAUMA AND EXCESSIVE WEIGHT HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-00497 / 00498).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2009. A SUBSEQUENT REVISION AND JOINT WASH OUT WAS PERFORMED (B)(6) 2013 DUE TO A FALL. THE PATELLA AND TIBIAL BEARING WITH LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97768 VANGRD ANT STBLZD BRG 16X71 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 562260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R