BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 80 REFOBACIN BONE CEMENT R

    MDR report key: 7624192 · Received June 21, 2018

    Report

    Report Number
    3006946279-2018-00210
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Report Date
    April 17, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK171540
    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. AN INVESTIGATION HAS BEEN PERFORMED, CONSISTING OF A DOCUMENTARY REVIEW. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. AS THE PRODUCT WAS NOT RETURNED, BIOMET FRANCE WAS NOT ABLE TO ANALYZE THE PRODUCT. NO NON-CONFORMITY HAS BEEN DETECTED WHICH COULD BE LINKED TO THE ISSUE. ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. 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 HAS BEEN REPORTED THAT THE LIQUID WOULD NOT DISPERSE INTO THE OTHER CONTAINER.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THEREFORE IT WILL NOT BE POSSIBLE TO ANALYZE IT. AS THE LOT NUMBER COMMUNICATED WAS NOT CORRECT AND UP TO DATE, NO OTHER INFORMATION ON THE LOT NUMBER COULD BE COLLECTED, THE DEVICE HISTORY RECORD COULD NOT BEEN REVIEWED. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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. LOT NUMBER COMMUNICATED NOT CORRECT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE LIQUID WOULD NOT DISPERSE INTO THE OTHER CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466241 OPTIPAC 80 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A713E07270

    Patients

    Seq Age Sex Outcome Treatment
    1