BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD PS TIB BRG 10X71/75

    MDR report key: 2991597 · Received March 6, 2013

    Report

    Report Number
    0001825034-2013-00480
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THE MEDWATCH REPORT (B)(4) WAS SENT IN REGARDS TO THIS EVENT TO REPORT THE TIBIAL TRAY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 TO REPLACE TIBIAL TRAY AND BEARING DUE TO TUMOR DEVELOPMENT UNDER THE TIBIAL PLATEAU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95414 VANGRD PS TIB BRG 10X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 060320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R