BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 54/48MM

    MDR report key: 3111930 · Received May 14, 2013

    Report

    Report Number
    3002806535-2013-00076
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 19, 2012
    Report Date
    April 17, 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 Location
    UK
    Reporter Occupation
    ATTORNEY

    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.THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL REPRESENTATIVE THAT PATIENT UNDERWENT PRIMARY HIP SURGERY ON (B)(6), 2008. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213102 RECAP SHELL COCR PC 54/48MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1454468

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R