BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR HA/PC DIA56/50MM

    MDR report key: 5261382 · Received December 2, 2015

    Report

    Report Number
    3002806535-2015-04110
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    January 14, 2013
    Report Date
    November 3, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 22 STATES, "ASEPTIC LYMPHOCYTE-DOMINATED VASCULITIS ASSOCIATED LESION (ALVAL)." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2014-00308 AND 3002806535-2015-04110).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO ASEPTIC LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESIONS (ALVAL). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL NOTED ADDITIONAL ALLEGATIONS OF ELEVATED METAL IONS AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790223 RECAP SHELL COCR HA/PC DIA56/50MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1869477

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R