BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD PS+ TIB BRG 16X71/75

    MDR report key: 2991575 · Received March 6, 2013

    Report

    Report Number
    0001825034-2013-00481
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK041046
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, "THE PATIENT IS TO BE ADVISED OF THE LIMITATIONS OF THE RECONSTRUCTION, AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED. EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, EXCESSIVE WEIGHT, AND OBESITY HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, DISLOCATION, SUBLUXATION AND/OR WEAR."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT FALL AND TIBIA FRACTURE. THE TIBIA TRAY AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95594 VANGRD PS+ TIB BRG 16X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 875380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R