BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 46MM OD X 40MM ID

    MDR report key: 1882112 · Received October 25, 2010

    Report

    Report Number
    1825034-2010-00463
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    February 14, 2007
    Report Date
    September 28, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: LOOSENING AND OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY. 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. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2007 TO REMOVE AND REPLACE THE ACETABULAR CUP DUE TO LOOSENING. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP 46MM OD X 40MM ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 337450

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R