BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK EXCEED/GTS PROSTHESIS

    MDR report key: 9283691 · Received November 6, 2019

    Report

    Report Number
    3002806535-2019-00844
    Event Type
    Injury
    Date Received
    November 6, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER. THIS EVENT WILL BE REPORTED BY MEDWATCH FACILITY FRANCE BIOMET ¿ 3006946279.

    Description of Event or Problem · 0

    REVISION DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO REVISIONS DUE TO PAIN OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080012 UNK EXCEED/GTS PROSTHESIS HIP PROSTHESIS JDI BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R