BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR GLENOID NON-CONSTRAINED ALL POLY 4MM

    MDR report key: 1770884 · Received July 27, 2010

    Report

    Report Number
    1825034-2010-00287
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K992119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.(B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B) (6) 2003. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B) (6) 2010, DUE TO PAIN. THE GLENOID COMPONENT AND OFFSET HEAD WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MODULAR GLENOID NON-CONSTRAINED ALL POLY 4MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 566470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R