BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALU FEM HD D28/+3.5/5 42/12-14

    MDR report key: 5732051 · Received June 17, 2016

    Report

    Report Number
    3006946279-2016-00193
    Event Type
    Injury
    Date Received
    June 17, 2016
    Report Date
    May 19, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI, DATE EXPLANTED - NI. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051411. 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

    PATIENT'S LEGAL COUNSEL REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ALLEGATIONS OF FRACTURED FEMORAL HEAD. 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
    387968 ALU FEM HD D28/+3.5/5 42/12-14 PROSTHESIS, HIP LZO BIOMET FRANCE S.A.R.L. N/A 0000148040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R