BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIPAC 40 REFOBACIN BONE CEMENT R-3

    MDR report key: 8599661 · Received May 10, 2019

    Report

    Report Number
    3006946279-2019-00253
    Event Type
    Death
    Date Received
    May 10, 2019
    Date of Event
    January 25, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 AND OF THE TESTING OF A RETAINED SAMPLE OF THE SAME BATCH THAN THE INVOLVED DEVICE. THE REVIEW OF THE PRODUCT MANUFACTURING RECORDS AND THE STERILIZATION CERTIFICATE SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF ZIMMER BIOMET. THE REVIEW OF THE RAW MATERIAL CERTIFICATES DEMONSTRATE THAT THE RAW MATERIALS WERE COMPLYING TO SPECIFICATIONS. THE ANALYSIS OF THE RETAINED SAMPLE DID NOT SHOW ANY UNUSUAL OBSERVATION DURING MIXING, HANDLING OR SETTING. THE REVIEW OF THE COMPLAINT HISTORY SHOWED THAT THIS IS THE ONLY DEATH EVENT FOR THE INVOLVED BATCH OF PRODUCTS. THE SURGICAL NOTES AND THE PATIENT MEDICAL RECORDS WERE NOT COMMUNICATED, HOWEVER THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS THE BONE CEMENT IMPLANTATION SYNDROME. 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 DURING THE SURGERY A CEMENTED ORTHOPEDIC PROTHESIS WAS IMPLANTED ON (B)(6) 2019. PATIENT'S BLOOD PRESSURE DROPPED. BRADYCHARDIA AND DEATH OCCURED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). DEVICE NOT EVALUATED AS THE REFERENCE AND BATCH NUMBERS WERE NOT COMMUNICATED, AND DEVICE WAS NOT RETURNED TO MANUFACTURER. 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 WAS REPORTED THAT DURING THE SURGERY A CEMENTED ORTHOPEDIC PROTHESIS WAS IMPLANTED ON (B)(6) 2019. PATIENT'S BLOOD PRESSURE DROPPED. BRADYCARDIA AND DEATH OCCURED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391924 OPTIPAC 40 REFOBACIN BONE CEMENT R-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. 817AA01380

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death