BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXCEED HIP

    MDR report key: 5851403 · Received August 5, 2016

    Report

    Report Number
    3002806535-2016-00672
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 6, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. REQUESTED, NOT RETURNED FROM HOSPITAL.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT HIP REVISION DUE TO DISLOCATION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502613 UNKNOWN EXCEED HIP PROSTHESIS, HIP KWA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R