BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 44MM HEAD DIAMETER

    MDR report key: 1901796 · Received November 17, 2010

    Report

    Report Number
    1825034-2010-00537
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    July 17, 2008
    Report Date
    October 19, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: POSSIBLE ADVERSE EFFECT #1- MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    INFORMATION RECEIVED SUGGESTS THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE DUE TO METAL HYPERSENSITIVITY. REVIEW OF INVOICE HISTORY REVEALED THAT PATIENT UNDERWENT HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2008 AND WAS REVISED ON (B)(6) 2008. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 44MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 664420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R