BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 40 -3

    MDR report key: 22676234 · Received July 31, 2025

    Report

    Report Number
    3006946279-2025-00101
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868358319
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00887868214578. G2 - FOREIGN: FRANCE 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. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. VISUAL EXAMINATION OF PROVIDED PICTURE IDENTIFIED A MONOMER AMPOULE BROKEN AS INTENDED. THE MONOMER LIQUID WAS EMPTIED INTO A CONTAINER. THERE IS BROWN FOREIGN DEBRIS IN THE LIQUID. IT IS NOT POSSIBLE TO DRAW CONCLUSIONS ABOUT THE NATURE OF THIS DEBRIS BASED ON THE PHOTO. 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. 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 DURING SURGERY, WHILE PREPARING THE BONE CEMENT, DEBRIS, POTENTIALLY GLASS, WAS DISCOVERED INSIDE THE STERILE PACKAGING OF THE MONOMER REAGENT. IT WAS NOTED THAT THE PACKAGING APPEARED INTACT. AN ALTERNATIVE BONE CEMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO KNOWN IMPACTS OR CONSEQUENCES REPORTED FOR THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417642 BIOMET BONE CEMENT R 40 -3 BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AV43DK0114 00887868358319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown