BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 42MM

    MDR report key: 2344956 · Received November 22, 2011

    Report

    Report Number
    0001825034-2011-01046
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    July 14, 2011
    Report Date
    October 27, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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: UNDER POSSIBLE ADVERSE EFFECTS, #4 STATES,"LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." THIS IS MDR THREE OF FOUR (1825034-2011-0001043 AND 01045 THROUGH 01047) FOR THIS EVENT. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO PAIN, LOOSENING AND EROSION OF BONE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 42MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 134590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R