BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 40 REFOBACIN BONE CEMENT R

    MDR report key: 6055420 · Received October 25, 2016

    Report

    Report Number
    3006946279-2016-00393
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    April 6, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    PK051496
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET U.S. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. REPORTED EVENT WAS UNABLE TO BE CONFIRMED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    LONG SETTING TIME OF 14-15 MINUTES FOR THE BONE CEMENT. THIS DID NOT CAUSE A DELAY OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704513 OPTIPAC-S 40 REFOBACIN BONE CEMENT R BONE CEMENT LOD BIOMET FRANCE S.A.R.L. N/A A526B18710

    Patients

    Seq Age Sex Outcome Treatment
    1