BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC DIA54/48MM

    MDR report key: 4132895 · Received October 1, 2014

    Report

    Report Number
    3002806535-2014-00216
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    February 4, 2015
    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
    IT
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO REVISION PROCEDURE HAS OCCURED SO 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. EXPIRATION DATE - UNKNOWN . IMPLANT DATE - (B)(6) 2006 (EXACT DATE UNKNOWN). MANUFACTURE DATE - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED. THIS IS 2 OF 3 MEDWATCH REPORTS BEING SUBMITTED FOR THE SAME EVENT. PLEASE SEE: 3002806535-2014-00215 / 00217.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON FEB. 4, 2015 INCLUDING THE LOT NUMBER. ALL INFORMATION RELATED TO THIS WAS INCLUDED IN THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT BILATERAL RECAP RESURFACING PROCEDURES IN (B)(6) OF 2005. BILATERAL REVISIONS WERE PERFORMED IN (B)(6) 2006 DUE TO UNKNOWN REASONS. PATIENT CURRENTLY STATES HE HAS ELEVATED METAL ION LEVELS, BUT DOES NOT WANT TO REVISE THE IMPLANTS AS THEY WORK WELL. NO FURTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612319 RECAP SHELL COCR PC DIA54/48MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1181219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention