BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RECAP 48MM HEAD

    MDR report key: 5957295 · Received September 16, 2016

    Report

    Report Number
    3002806535-2016-00750
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 11, 2016
    Report Date
    August 17, 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
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE CUP, HEAD, AND SLEEVE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608985 UNKNOWN RECAP 48MM HEAD PROSTHESIS, HIP KWA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R