BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 1X40-3

    MDR report key: 22278612 · Received June 18, 2025

    Report

    Report Number
    3006946279-2025-00084
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 26, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    70887868358387
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. VISUAL EXAMINATION OF PROVIDED PICTURES AND VIDEO IDENTIFIED AN INNER CEMENT POUCH WITH THE SEALING OPENED. SOME POLYMER POWDER CAN LEAK OUT FROM THE FUNNEL. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 ¿ FOREIGN ¿ CHINA. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172408 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, A HOLE WAS OBSERVED IN THE INNER STERILE PACKAGE. STERILE CONDITIONS APPEARED COMPROMISED. THE INNER STERILE PACKAGE WAS NOT OPENED. IT WAS DESTROYED. THERE WAS NO IMPACT ON THE PROCEDURE DUE TO THIS ISSUE. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355913 REFOBACIN BONE CEMENT R 1X40-3 BONE CEMENT LOD BIOMET FRANCE S.A.R.L. V07ABC0804 70887868358387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown