BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR 48MM

    MDR report key: 2735999 · Received September 7, 2012

    Report

    Report Number
    3002806535-2012-00254
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    July 4, 2012
    Report Date
    August 9, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 4 OF 4 REPORTS RELATED TO THE SAME EVENT. (SEE 3002806535-2012-002512/254).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2006. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HD COCR 48MM M2A MAGNUM MODULAR HEAD KWA BIOMET UK LTD. N/A 1135658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R