BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR

    MDR report key: 2942205 · Received February 4, 2013

    Report

    Report Number
    3002806535-2013-00013
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 8, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS IS 1 OF 2 MDR REPORTS FOR THE SAME EVENT (SEE: 3002806535-2013-00013/014).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2010. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO HIP INSTABILITY. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46669 M2A MAGNUM MODULAR HD COCR M2A MAGNUM MODULAR HEAD KWA BIOMET UK LTD. N/A 1800822

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R