BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF DOMED LAT MEN BRNG SZ 3 UK

    MDR report key: 11875214 · Received May 25, 2021

    Report

    Report Number
    3002806535-2021-00223
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279103836
    PMA / PMN Number
    P01004
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND (B)(4) COMPLAINT REPORTED WITH THE ITEM 161687 INCLUDING INITIATING COMPLAINT . WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT FELL AND HAD TO HAVE A REVISION PROCEDURE DUE TO INSTABILITY WAS PERFORMED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN (B)(6) 2021. SUBSEQUENTLY, THE PATIENT FELL AND HAD TO HAVE A REVISION PROCEDURE DUE TO INSTABILITY WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775496 OXF DOMED LAT MEN BRNG SZ 3 UK KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 6092495 05019279103836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R