BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 1870965 · Received October 8, 2010

    Report

    Report Number
    3002806535-2010-00076
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    PT UNDERWENT HIP PROCEDURE ON (B)(6) 2010. HOSPITAL REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2010, DUE TO INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD KWA BIOMET UK LTD. NA 1435786

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R