BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP FEM HD COCR CEMENTED 44MM

    MDR report key: 3122170 · Received May 21, 2013

    Report

    Report Number
    3002806535-2013-00087
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    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. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. INITIAL REPORTER - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED. THIS IS 2 OF 2 MDR REPORTS FOR THE SAME EVENT (SEE: 3002806535-2013-00086/087).

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 ALLEGEDLY DUE TO PAIN AND INCREASED BLOOD ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224897 RECAP FEM HD COCR CEMENTED 44MM RECAP FEMORAL HEAD KXA BIOMET UK LTD. N/A 1152680

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R