BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR BIOMET FEM HD STD NK

    MDR report key: 5721439 · Received June 13, 2016

    Report

    Report Number
    3002806535-2016-00362
    Event Type
    Injury
    Date Received
    June 13, 2016
    Report Date
    May 14, 2016
    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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 K042037. ADDITIONAL EVENT FOR THIS PATIENT REPORTED ON 1825034-2016-02022. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    DURING A REIMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED CARDIAC ARYTHMIA AND REQUIRED CPR. THERE WAS A DELAY LESS THAN THIRTY MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375290 36MM COCR BIOMET FEM HD STD NK PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1466097

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R