BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REFOBACIN BONE CEMENT R

    MDR report key: 18299701 · Received December 11, 2023

    Report

    Report Number
    3006946279-2023-00100
    Event Type
    Injury
    Date Received
    December 11, 2023
    Report Date
    January 9, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    Removal / Correction 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. 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. 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. H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. MEDICAL PRODUCT: ITEM#: UNKNOWN; LOT#: UNKNOWN; ITEM NAME: UNKNOWN PERSONA PK 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

    IT WAS REPORTED THAT THREE (3) PATIENTS IN THE FIXED BEARING GROUP WERE REVISED DUE TO ASEPTIC LOOSENING DURING THE STUDY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THE STUDY REPORTED THREE PATIENTS WERE REVISED DUE TO ASEPTIC 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
    2071391 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