BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CMENT R 1X40 JP

    MDR report key: 21795253 · Received April 8, 2025

    Report

    Report Number
    3006946279-2025-00045
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 21, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    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). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 ¿ FOREIGN ¿ JAPAN 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 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND SHOWS THAT THE POWDER HAS BEEN DEPOSITED IN A BOWL FOR THE MIXING. WE CAN SEE A DISCOLORATION OF THE POWDER THAT MIGHT BE A RESIDUE OF RAW MATERIAL (COPO E) BUT THIS COULD NOT BE CONFIRMED ONLY WITH PICTURES. THE PRODUCT IDENTIFICATION IS CONFIRMED WITH THE STICKER ON THE PACKAGING. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL 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. 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. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. 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 THE SURGERY THE SURGEON DISCOVERED THAT THE POLYMER WAS CONTAMINATED WITH A FOREIGN SUBSTANCE.. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. APART FROM 2 TO 3-MINUTE DELAY IN THE SURGERY TO REPLACE THE PRODUCT, THERE WAS NO IMPACT ON THE PATIENT. NO FURTHER INFORMATION WAS REQUESTED.

    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
    753326 BIOMET BONE CMENT R 1X40 JP BONE CEMENT LOD BIOMET FRANCE S.A.R.L. V05BAK2410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown