BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ AA RM PMA

    MDR report key: 17850206 · Received October 2, 2023

    Report

    Report Number
    3002806535-2023-00328
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 19, 2023
    Manufacturer
    .
    Product Code
    NRA
    UDI-DI
    05019279783144
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: OXFORD UNI TWIN-PEG FEMORAL XS; ITEM#: 166940; LOT#: J6383015. OXF ANAT BRG RT X-SM 6MM PMA; ITEM# :160793; LOT#: 7052325. G2 - FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, A4, B4, B5, B7, G3, G6, H1, H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THERE IS A MEDIAL UNICOMPARTMENTAL ARTHROPLASTY OF THE RIGHT KNEE. THERE IS TIBIAL IMPLANT LOOSENING AND SUBSIDENCE GREATEST POSTERIORLY AND MEDIALLY WITH MILD KNEE VARUS ALIGNMENT. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY AND APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO THE SUBSIDENCE OF THE TIBIAL COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341080 OXF UNI TIB TRAY SZ AA RM PMA OXFORD CEMENTED TIBIAL TRAY NRA . N/A 6764110 05019279783144

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R