BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD DIA36/ 0MM 12/14

    MDR report key: 5839975 · Received August 2, 2016

    Report

    Report Number
    3002806535-2016-00640
    Event Type
    Injury
    Date Received
    August 2, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 3, 2016
    Manufacturer
    BIOMET UK LTD.
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051411. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02845 / 02846 AND 3002806535-2016-00640). DISCARDED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO DISLOCATION AND METALLOSIS. THERE WAS A DELAY OF TWO HOURS. THE FEMORAL HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492393 DELTA CERAMIC FEM HD DIA36/ 0MM 12/14 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2015111898

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R