BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF DOMED LAT TIB TRAY SZ B-UK

    MDR report key: 8673615 · Received June 6, 2019

    Report

    Report Number
    3002806535-2019-00485
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 7, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF DOMED LAT MEN BRNG SZ 5 UK, CATALOG #: 161689, LOT #: 3428009. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468672 OXF DOMED LAT TIB TRAY SZ B-UK KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 3638972

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R