BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CMNT R 1X40 JP

    MDR report key: 21311764 · Received February 5, 2025

    Report

    Report Number
    3006946279-2025-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 10, 2025
    Report Date
    May 6, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    00887868358494
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G1-2, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D2, G1-2. D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). 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. VISUAL EXAMINATION OF PROVIDED PICTURES IDENTIFIED A SMALL DEBRIS THAT LOOKS LIKE TO A PIECE OF POUCH PAPER. VISUAL EXAMINATION OF RETURNED PRODUCT IDENTIFIED POLYMER POWDER RETURNED IN AN OPEN POUCH, NOT CORRESPONDING TO THE INITIAL PACKAGING. THE POWDER WAS SPILL OUT TO FIND THE FOREIGN SUBSTANCE, NONE HAS BEEN OBSERVED. HOWEVER, IT WAS NOTICED LITTLE POWDER AGGLOMERATES, PROBABLY DUE TO HUMIDITY EXPOSURE DURING TRANSPORT. PATIENT LABELS WERE RETURNED WITH THE LOT NUMBER REPORTED IN THE COMPLAINT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2 - FOREIGN: JAPAN. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, DEBRIS WERE NOTICED IN THE STERILE CEMENT POLYMER PACKAGE. AN ALTERNATIVE CEMENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCE OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134010 REFOBACIN BONE CMNT R 1X40 JP BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. W50CAL0109 00887868358494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown