BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT

    MDR report key: 5678079 · Received May 25, 2016

    Report

    Report Number
    3006946279-2016-00090
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 29, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K150850. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, THE CEMENT DID NOT HARDEN. THIS RESULTED IN AN UNKNOWN DELAY IN PROCEDURE. ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334633 OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A521B04770

    Patients

    Seq Age Sex Outcome Treatment
    1