BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF DOMED LAT TIB TRAY SZ D-UK

    MDR report key: 9189853 · Received October 15, 2019

    Report

    Report Number
    3002806535-2019-00803
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    November 27, 2017
    Report Date
    November 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 IN RELATION TO THIS EVENT. 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.

    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 A BEARING REVISION DUE TO A BEARING DISLOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BEARING REVISION DUE TO A BEARING DISLOCATION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). CONCOMITANT MEDICAL PRODUCTS: OXF DOMED LAT MEN BRNG MD SZ 3, CATALOG #: 161694, LOT #: 2642731. ADDITIONAL MDR REPORT WAS FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2019-00804. 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 A PATIENT UNDERWENT A BEARING REVISION DUE TO A BEARING DISLOCATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988750 OXF DOMED LAT TIB TRAY SZ D-UK KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2476971

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R