BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38 MODULAR HEAD

    MDR report key: 1071246 · Received July 7, 2008

    Report

    Report Number
    1825034-2008-00190
    Event Type
    Injury
    Date Received
    July 7, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFO IS AVAILABLE. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF THE 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. EVAL OF RETURNED DEVICE FOUND THE BEARING SURFACE TO HAVE A CLOUDY APPEARANCE AND A DEEP SCRATCH ON THE COLLAR OF THE TAPER. IT IS POSSIBLE THAT THE DEEP SCRATCH OCCURRED DURING THE REMOVAL OF THE MODULAR HEAD COMPONENT. EXAMINATION WAS UNABLE TO DETERMINE ANY IMPLANT RELATED ISSUES THAT WOULD HAVE LEAD TO THE REVISION. THIS REPORT FILED ON JULY 7, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL HIP ARTHROPLASTY THREE (3) YEARS AGO. SUBSEQUENTLY, PT UNDERWENT REVISION PROCEDURE WHERE METALOSIS AND CYSTS WERE IDENTIFIED. NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38 MODULAR HEAD KWA BIOMET, INC. NA 491750

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R