BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIP 60 REFOBACINE PLUS BONE CMT-3

    MDR report key: 8925050 · Received August 23, 2019

    Report

    Report Number
    3006946279-2019-00371
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 30, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT ANALYSIS PERFORMED ON THE PRODUCT RETURNED SHOWED THAT THE MONOMER LIQUID ENTERS IN THE CYLINDER, HOWEVER, IT DID NOT MIX CORRECTLY WITH THE CEMENT POWDER. INDEED, THE CEMENT WAS NOT HOMOGENEOUS. THEREFORE, THE PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT. RESERVE SAMPLE FROM THE SAME LOT WAS TESTED UNDER STANDARDIZED CONDITIONS. THE PRODUCT DID NOT SHOW ANY UNUSUAL BEHAVIOR DURING MIXING, HANDLING OR SETTING. THE REPORTED BEHAVIOR OF THE CEMENT COULD NOT BE REPRODUCED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT 2 061 PRODUCTS OPTIPAC 60 REFOBACIN PLUS BONE CEMENT-3, REFERENCE (B)(4), LOT NUMBER 844AC02045 WERE MANUFACTURED ON (B)(6) 2018, THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE EVENT DESCRIBED IN THE COMPLAINT. NO OTHER SIMILAR COMPLAINT HAS BEEN RECORDED FOR OPTIPAC 60 REFOBACIN PLUS BONE CEMENT-3, REFERENCE (B)(4), LOT NUMBER 844AC02045 ON THE REPORTED EVENT WITHIN ONE YEAR. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER MIXING THE CEMENT IT WAS NOTICED THAT THE POWDER AND MONOMER LIQUID DID NOT MIX COMPLETELY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT (B)(4) PRODUCTS OPTIPAC 60 REFOBACIN PLUS BONE CEMENT-3, REFERENCE 4721502084-3, LOT NUMBER 844AC02045 WERE MANUFACTURED ON 03 DECEMBER 2018. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT'S HAS BEEN REPORTED THAT AFTER MIXING THE CEMENT IT WAS NOTICED THAT THE POWDER AND MONOMER LIQUID DID NOT MIX COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719077 OPTIP 60 REFOBACINE PLUS BONE CMT-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. 844AC02045

    Patients

    Seq Age Sex Outcome Treatment
    1