BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL BEARING

    MDR report key: 1082243 · Received July 29, 2008

    Report

    Report Number
    1825034-2008-00201
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    JWH
    PMA / PMN Number
    K042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    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.

    Additional Manufacturer Narrative · 1

    BIOMET WAS NOTIFIED OF THIS EVENT VIA LETTER DATED JUNE 26, 2008 RECEIVED JUNE 30, 2008. SUBSEQUENTLY, LETTER DATED JULY 8, 2008 WAS RECEIVED ON JULY 28, 2008, REQUESTING ADDITIONAL INFORMATION REGARDING REPORT. BIOMET SUBMITTED INITIAL REPORT 1825034-2008-00201 ON JULY 29, 2008 PROVIDING DESCRIPTION OF INCIDENT AND RESULTS OF INVESTIGATION. AS DEVICE WAS NOT AVAILABLE FOR EVALUATION, DEVICE HISTORY RECORDS AND COMPLAINT RECORDS WERE REVIEWED. ON AUGUST 8, 2008, REP RELAYED DURING TELEPHONE CONVERSATION THAT DETAILS PROVIDED IN BIOMET'S INITIAL REPORT SATISFY REQUEST FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2006. SUBSEQUENTLY, PATIENT UNDERWENT REVISION OF RIGHT TOTAL KNEE IMPLANT IN 2008, DUE TO MECHANICAL LOOSENING OF POLYETHYLENE ON TIBIAL TRAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2006. SUBSEQUENTLY, PATIENT UNDERWENT REVISION OF RIGHT TOTAL KNEE IMPLANT IN 2008, DUE TO MECHANICAL LOOSENING OF POLYETHYLENE ON TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD TIBIAL BEARING PROSTHESIS, KNEE COMPONENT JWH BIOMET INC. N/A 066570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R