BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT X-SM 4MM PMA

    MDR report key: 6917355 · Received October 5, 2017

    Report

    Report Number
    3002806535-2017-00927
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    August 31, 2017
    Report Date
    March 28, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 154721, OXF UNI TIB TRAY SZ B RM PMA, 414780. 161467, OXF TWIN-PEG CMNTD FEM XS PMA, 446530.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY. ONLY THE BEARING WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698322 OXF ANAT BRG RT X-SM 4MM PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 386670

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R