BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 54/48MM

    MDR report key: 2941802 · Received February 4, 2013

    Report

    Report Number
    3002806535-2013-00012
    Event Type
    Injury
    Date Received
    February 4, 2013
    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 Location
    NL
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT ALLEGES ELEVATED METAL ION LEVELS AND POSSIBLE PSEUDOTUMOR. NO REVISION PROCEDURE HAS BEEN PERFORMED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46884 RECAP SHELL COCR PC 54/48MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1495934

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization