BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR SHOULDER POROUS COATED GLENOID MEDIUM TRAY

    MDR report key: 2220946 · Received August 23, 2011

    Report

    Report Number
    1825034-2011-00739
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    May 30, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    K030710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 FOUR STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND/OR EXCESSIVE ACTIVITY". THIS IS MDR ONE OF TWO (1825034-2011-00739 THROUGH 00740) FOR THIS EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MODULAR SHOULDER POROUS COATED GLENOID MEDIUM TRAY PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 544000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R