BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 75MM

    MDR report key: 3203794 · Received July 3, 2013

    Report

    Report Number
    0001825034-2013-02460
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2013 DUE TO TIBIAL SUBSIDENCE. THE BEARING AND TIBIAL TRAY WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304405 BIOMET CC CRUCIATE TRAY 75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J2370432

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R