BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE-PIECE CUP 38MM X 56 OD

    MDR report key: 1960486 · Received January 13, 2011

    Report

    Report Number
    1825034-2011-00031
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2005. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND HAD ELEVATED SERUM ION LEVELS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 AND THE ACETABULAR CUP, MODULAR HEAD AND TWO SCREWS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM ONE-PIECE CUP 38MM X 56 OD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 883360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R