BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 54/48MM

    MDR report key: 3140419 · Received May 31, 2013

    Report

    Report Number
    3002806535-2013-00091
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    October 10, 2011
    Report Date
    May 1, 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

    ADDITIONAL INFORMATION WAS RECEIVED INCLUDING IMPLANT AND EXPLANT DATES AND FURTHER INFORMATION RELATED TO THE SECOND PROCEDURE.

    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. IMPLANT DATE - (B)(6) 2010 (EXACT DATE UNKNOWN). EXPLANT DATE - (B)(6) 2011 (EXACT DATE UNKNOWN). INITIAL REPORTER - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNCIL THAT PATIENT UNDERWENT LEFT HIP ARTHROPLASTY IN (B)(6) 2010. REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2011, FOR UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A BILATERAL REVISION PROCEDURE OCCURRED ON (B)(6) 2011 FOR UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED 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
    242398 RECAP SHELL COCR PC 54/48MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1727807

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R