BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38 CUP

    MDR report key: 1071245 · Received July 7, 2008

    Report

    Report Number
    1825034-2008-00189
    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 THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFO IS AVAILABLE. CURRENT INFO IS SUFFICIENT 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. EVAL OF RETURNED DEVICE FOUND THE INTERIOR BEARING SURFACE TO HAVE A CLOUDY APPEARANCE. EXAMINATION WAS UNABLE TO DETERMINE ANY IMPLANT RELATED ISSUES THAT WOULD HAVE LEAD TO THE REVISION. THIS REPORT FILED IN 2008.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38 CUP KWA BIOMET, INC. NA 404880

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R