BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CMNT R 1X40 JP

    MDR report key: 21974911 · Received May 7, 2025

    Report

    Report Number
    3006946279-2025-00054
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 29, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    00887868358494
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 00880304990197. G2: JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540 INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED A CEMENT PACK FOLDING BOX CONTAINING THE PATIENT LABELS AND THE POLYMER POUCHES NOT OPENED (ALUMINUM POUCH, OUTER POUCH, AND INNER POUCH). THE MONOMER POUCH WAS NOT RETURNED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL CERTIFICATE CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. THE REPORTED EVENT DID OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE, BUT REVIEW OF THE MEDICAL RECORDS HAS NOT BEEN PERFORMED, AS THE EVENT IS NOT RELATED TO THE MEDICAL PROCEDURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN DEBRIS WAS FOUND IN THE MONOMER PACKAGING. THE SURGEON USED ANOTHER PRODUCT TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449930 REFOBACIN BONE CMNT R 1X40 JP BONE CEMENT MBB BIOMET FRANCE S.A.R.L. W50CAL0109 00887868358494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown