BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT PRIMARY TIBIAL BEARING

    MDR report key: 1081146 · Received July 15, 2008

    Report

    Report Number
    1825034-2008-00196
    Event Type
    Injury
    Date Received
    July 15, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K982869
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    FOLLOW UP IS IN RESPONSE TO FDA LETTER RECEIVED AUGUST 4, 2008 DATED JULY 28, 2008, REQUESTING TREND ANALYSIS INFORMATION ON THE DEVICE ASSOCIATED WITH THIS REPORT. BIOMET HAS PERFORMED A THREE (3) YEAR REVIEW OF OUR COMPLAINT SYSTEM AND IDENTIFIED ONLY TWO (2) REPORTS OF THIS NATURE ASSOCIATED WITH THIS TYPE DEVICE. BOTH EVENTS WERE REPORTED TO BIOMET INC. JUNE 25, 2008 VIA MEDWATCH REPORT FROM THE SAME USER FACILITY. THE FIRST REPORT BEING THIS ONE AND THE SECOND REPORT IS MEDWATCH REPORT #1825034-2008-00194. BOTH REPORTS INDICATED THAT WHEN THE KNEE WAS ENTERED, METALLOSIS AND DARKENING OF THE SYNOVIUM WAS PRESENT. THE REPORTED DEVICES WERE NOT AVAILABLE FOR EVALUATION; HOWEVER, IN EFFORT TO FURTHER INVESTIGATE, DEVICE HISTORY RECORDS FOR THE TWO (2) DEVICES WERE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY IN 1999. SUBSEQUENTLY, PT WAS REVISED IN 2008. UPON ENTERING THE KNEE, VERY BLACK DARKENED CHARCOAL GRAY SYNOVITIS WAS ENCOUNTERED, IT APPEARED TO BE METALLOSIS THROUGHOUT THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENT PRIMARY TIBIAL BEARING PROSTHESIS, KNEE COMPONENT JWH BIOMET, INC. NA 182200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R