BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    MDR report key: 7272852 · Received February 15, 2018

    Report

    Report Number
    3006946279-2018-00065
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    K150850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BEEN REVIEWED AS THE LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PREPARATION OF THE BONE CEMENT, THE MONOMER LIQUID WOULD NOT DISPENSE INTO THE CYLINDER. THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY SUPERIOR TO 30 MN.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE , FOREIGN - (B)(6). THE ITEM AND THE BATCH ARE UNKNOWN, BY CONSEQUENCE THE UDI IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED FOR INVESTIGATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION OF THE BONE CEMENT, THE MONOMER LIQUID WOULD NOT DISPENSE INTO THE CYLINDER. THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY SUPERIOR TO 30 MN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117879 OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1