BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CEMENT R 2X20-3

    MDR report key: 24311951 · Received February 11, 2026

    Report

    Report Number
    3006946279-2026-00007
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    December 10, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    00887868358371
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D:10: 159582, OXF ANAT BRG RT LG SIZE 3 PMA, LOT 7500507; 154725, OXF UNI TIB TRAY SZ D RM PMA, LOT J7506082; 166943, OXFORD UNI TWIN-PEG FEMORAL LG, LOT J7670007. G2: FOREIGN - EVENT OCCURRED IN GERMANY. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY LEGAL THAT A PATIENT WAS REVISED TO A TOTAL KNEE PROSTHESIS APPROXIMATELY ONE YEAR AND NINE MONTHS POST AN INITIAL RIGHT MEDIAL UNICONDYLAR KNEE ARTHROPLASTY. ABOUT A YEAR AND A HALF POST IMPLANTATION, THE PATIENT PRESENTED WITH PAIN WITHOUT A KNOWN TRAUMA OR INJURY. CT SCANS SHOWED FEMORAL COMPONENT IMPLANT FRACTURE WITH FRAGMENT AND BEARING DISPLACEMENT, FEMORAL RADIOLUCENCIES INDICATING LOOSENING, PRONOUNCED SOFT TISSUE CALCIFICATIONS, AND MARKED JOINT EFFUSION. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379758 REFOBACIN BONE CEMENT R 2X20-3 ORTHOPAEDIC CEMENT, ANTIMICROBIAL MBB BIOMET FRANCE S.A.R.L. W39BAG2405 00887868358371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.