BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REFOBACIN BONE CEMENT R

    MDR report key: 18299707 · Received December 11, 2023

    Report

    Report Number
    3006946279-2023-00101
    Event Type
    Injury
    Date Received
    December 11, 2023
    Report Date
    December 15, 2023
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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). D10. MEDICAL PRODUCT: ITEM#: UNKNOWN; LOT#: UNKNOWN; ITEM NAME: UNKNOWN OXFORD FEMORAL COMPONENT; ITEM#: UNKNOWN; LOT#: UNKNOWN; ITEM NAME: UNKNOWN OXFORD TIBIAL COMPONENT; ITEM#: UNKNOWN; LOT#: UNKNOWN; ITEM NAME: UNKNOWN OXFORD BEARING; 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. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE STUDY REPORTED TWO PATIENTS WERE REVISED DUE TO LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071397 UNKNOWN REFOBACIN BONE CEMENT R BONE CEMENT LOD BIOMET FRANCE S.A.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE