BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 50MM HEAD DIAMETER

    MDR report key: 1939832 · Received December 28, 2010

    Report

    Report Number
    1825034-2010-00686
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    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. THIS REPORT FILED (B)(6), 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2005 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO SUSPECTED METAL DEBRIS, METALOSIS OR A PSEUDOTUMOR. DURING THE PROCEDURE, THERE WERE NO ABNORMALITIES NOTED. THE SURGEON ELECTED TO REMOVE AND REPLACE THE MODULAR HEAD AND ACETABULAR CUP. THE ACETABULAR CUP WAS NOT MANUFACTURED BY BIOMET ORTHOPEDICS, INC. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 50MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 728360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R