BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD ANT STBLZD BEARING 10X75

    MDR report key: 3875275 · Received June 16, 2014

    Report

    Report Number
    0001825034-2014-05565
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 22, 2012
    Report Date
    May 26, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK050222
    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 "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05565 / 05566).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6), 2012 AND (B)(6), 2014 DUE TO INSTABILITY. THE TIBIAL BEARINGS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352566 VANGRD ANT STBLZD BEARING 10X75 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 562310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R