BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC SOFTPAC HIPSET

    MDR report key: 5508930 · Received March 17, 2016

    Report

    Report Number
    3006946279-2016-00016
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Report Date
    September 26, 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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. 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 K051496. SURGEON DID NOT APPROVE FOR RETURN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE. DURING THE PROCEDURE WHILE PREPARING THE CEMENT MIXTURE, THE MONOMER LIQUID WOULD NOT DISPENSE AND WOULD NOT ENTER THE CYLINDER. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164672 OPTIPAC SOFTPAC HIPSET BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A440A18098

    Patients

    Seq Age Sex Outcome Treatment
    1