BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIPAC 80 REFOBACIN BONE CEMENT R-3

    MDR report key: 10572077 · Received September 23, 2020

    Report

    Report Number
    3006946279-2020-00190
    Event Type
    Death
    Date Received
    September 23, 2020
    Date of Event
    June 21, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDZ
    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. D11 : AVENIR STEM LATERAL, CEMENTED 9 TAPER 12/14 - REFERENCE : (B)(4), - LOT : 2836784. X-RAYS HAS BEEN PROVIDED AND SHOWS A DISLOCATED MEDICAL FRACTURE OF THE NECK OF THE LEFT FEMUR. THERE ARE NO DETAILS ON THE X-RAYS TO SHOW THE SHOCK DUE TO THE CEMENT. THE SURGICAL NOTES HAS BEEN REVIEWED. PRODUCT WAS NOT RETURNED. THE REPORTED EVENT WAS CONFIRMED BY SURGICAL NOTES REVIEW. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO OTHER COMPLAINT ON PATIENT DEATH WAS RECORDED ON THE BATCH SINCE EVER, AND NO OTHER COMPLAINT ON PATIENT DEATH WAS RECORDED ON THE REFERENCE SINCE EVER. RESERVE SAMPLE FROM THE SAME LOT WAS TESTED UNDER STANDARDIZED CONDITIONS. THE PRODUCT DID NOT SHOW ANY UNUSUAL BEHAVIOR DURING MIXING, HANDLING OR SETTING. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO 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 THE PATIENT DEATH AFTER CEMENTING A FEMORAL STEM.

    Additional Manufacturer Narrative · 1

    CMP (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES : AVENIR STEM. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6).. THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BEEN REVIEWED AS THE REFERENCE AND THE LOT NUMBER WAS NOT COMMUNICATED. TO DATE, THE FACT THAT THE CEMENT IS A ZIMMER BIOMET CEMENT IS NOT CONFIRMED. INVESTIGATION IS ONGOING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEATH AFTER CEMENTING A FEMORAL STEM. TO DATE, THE CEMENT BRAND IS NOT CONFIRMED. THE CURRENT REPORT IS SUBMITTED AS A CONSERVATIVE APPROACH IN WAITING FOR THE CONFIRMATION THAT A ZIMMER BIOMET CEMENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041009 OPTIPAC 80 REFOBACIN BONE CEMENT R-3 ORTHOPAEDIC CEMENT, MEDICATED JDZ BIOMET FRANCE S.A.R.L. 850DA01730

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death SEE H10.| SEE H10