BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38 MM HEAD DIAMETER

    MDR report key: 1882084 · Received October 25, 2010

    Report

    Report Number
    1825034-2010-00468
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    July 12, 2006
    Report Date
    September 28, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A SURGEON CONFERENCE PRESENTATION, REVISION PROCEDURES RELATED TO BIOMET PRODUCT WERE BEING DISCUSSED. SUBSEQUENTLY, BIOMET CONTACTED THE SURGEON'S OFFICE TO OBTAIN MORE DETAILED INFORMATION REGARDING THE EVENTS DISCUSSED DURING THE CONFERENCE. IT WAS CONFIRMED THAT BIOMET HAD NOT BEEN NOTIFIED OF THE EVENTS AND INFORMATION WAS SUPPLIED TO BIOMET ON (B)(6) 2010. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE REACTIONS #1, IT STATES, "MATERIAL SENSITIVITY REACTIONS". THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2006, DUE TO A METAL HYPERSENSITIVITY REACTION. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD COMPONENT 38 MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 958340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R