BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 80 REFOB BONE CMT R-3

    MDR report key: 14942147 · Received July 7, 2022

    Report

    Report Number
    3006946279-2022-00070
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 7, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    04040029922385
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN SOURCE: (B)(6). PRODUCT WAS NOT RETURNED OR PICTURES NOT PROVIDED. DEVICE EVALUATION COULD NOT BE PERFORMED. THE DHR REVIEW CAN¿T BE PERFORMED AS THE ITEM/BATCH NUMBER WAS NOT PROVIDED. THIS DEVICE IS USED FOR TREATMENT. REPORTED EVENT IS NOT RELATED TO MEDICAL CONDITION. REVIEW OF MEDICAL RECORD IS NOT APPLICABLE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CONCOMITANT MEDICAL PRODUCT NUMBERS: REFERENCE NUMBER: 61.27.00-48, ITEM NAME: MODULAR-BIPOLAR SHELL 48, LOT: 3096595. REFERENCE NUMBER: 61.27.28-46, ITEM NAME: MODULAR-BIPOLAR INSERT 28/46, LOT: 3093076. REFERENCE NUMBER: 01422800, ITEM NAME: STAINLESS STEEL FEMORAL HEAD ATF, LOT:B798-211413. REFERENCE NUMBER: 2502104, ITEM NAME: CEMENTED SILENE STEM, LOT: B775-211409. REFERENCE NUMBER: 50.10.10, ITEM NAME BIOSEM II BONE PLUG, LOT: P72113B0421. WE HAVE BEEN PROVIDED WITH THE PRODUCT NUMBERS FOR THE REPORTED OPIPAC BONE CEMENT TOGETHER WITH THE CONCOMITANT MEDICAL PRODUCT NUMBERS. A REVIEW OF DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THIS ADDITIONAL INFORMATION DOES NOT ALTER THE PREVIOUSLY REPORTED EVALUATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REVISION SURGERY OF A COMPETITOR'S IMPLANT, IT SEEMED AS IF NOT CEMENTED. INVESTIGATION HAS BEEN COMPLETED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723878 OPTIPAC 80 REFOB BONE CMT R-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A AY31BD0107 04040029922385

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H