BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 2091641 · Received April 28, 2011

    Report

    Report Number
    3002806535-2011-00057
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 1, 2010
    Report Date
    April 1, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS REC'D. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPLANT DATE - (B)(6) 2010 (EXACT DATE UNK). THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    PT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6), 2008. REVISION PROCEDURE WAS PERFORMED IN THE (B)(6) OF 2010 DUE TO PERSISTENT PAIN. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R