BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 18254199 · Received December 4, 2023

    Report

    Report Number
    3002806535-2023-00405
    Event Type
    Injury
    Date Received
    December 4, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. MEDICAL PRODUCT: ITEM#:UNKNOWN ;LOT#: UNKNOWN ;ITEM NAME: UNKNOWN OXFORD FEMORAL COMPONENT; ITEM#:UNKNOWN ;LOT#: UNKNOWN ;ITEM NAME: UNKNOWN OXFORD BEARING ; ITEM#:UNKNOWN ;LOT#:UNKNOWN ;ITEM NAME: UNKNOWN REFOBACIN BONE CEMENT R; THERAPY DATE: UNKNOWN. H3-OTHER: DEVICE EVALUATION COULD NOT BE PERFORMED AS PART# AND LOT# UNKNOWN. ALSO DEVICE LOCATION IS UNKNOWN. G2-FOREIGN- ITALY. G2-LITERATURE- JOURNAL ARTICLE. NO DIFFERENCE IN MOBILE AND FIXED BEARING PARTIAL KNEE ARTHROPLASTY IN OCTOGENARIANS: A CLINICAL TRIAL (2023). RICCARDO D¿AMBROSI, FEDERICO VALLI, ALESSANDRO NUARA, ILARIA MARIANI, FABRIZIO DI FEO, NICOLA URSINO, MATTEO FORMICA, LAURA MANGIAVINI, MICHAEL HANTES, FILIPPO MIGLIORINI. HTTPS://DOI.ORG/10.1007/S00590-023-03537-7. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2023 - 00404. 3002806535 - 2023 - 00406. 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

    THE STUDY REPORTED TWO PATIENTS WERE REVISED DUE TO ASEPTIC LOOSENING. DUE DILIGENCE IS COMPLETED FOR THIS COMPLAINT; TO DATE WHATEVER ADDITIONAL INFORMATION RECEIVED HAS BEEN CAPTURED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283824 UNKNOWN OXFORD TIBIAL COMPONENT PROSTHESIS, KNEE NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H SEE H10 NARRATIVE.