BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 50/44MM

    MDR report key: 3181340 · Received June 21, 2013

    Report

    Report Number
    3002806535-2013-00108
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 21, 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. NO REVISION SURGERY HAS BEEN REPORTED. 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. DATE OF EVENT - UNKNOWN. INITIAL REPORTER - UNKNOWN. 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

    IT WAS REPORTED BY PATIENT'S LEGAL REPRESENTATIVE THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. THE CLAIM ALLEGES PATIENT HAS COMPLAINTS, PAIN AND INCREASED BLOOD ION LEVELS. NO REVISION PROCEDURE WAS REPORTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S NOTICE AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283145 RECAP SHELL COCR PC 50/44MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1153697

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization