BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 40 REFOBACIN REVISION

    MDR report key: 5529399 · Received March 28, 2016

    Report

    Report Number
    3006946279-2016-00024
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 26, 2016
    Report Date
    February 29, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. DEVICE AVAILABILITY - THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SEND TO THE FDA TO PROVIDE RESULTS. 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.

    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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE REVIEW OF MANUFACTURING DHR SHOWS THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. THE PRODUCT INSPECTION REVEALED THAT NO NON-CONFORMITY WAS DETECTED. A CAPA DETERMINATION HAS BEEN INITIATED IN ORDER TO IMPLEMENT ACTIONS TO AVOID THE RECURRENCE OF THIS TYPE OF ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. DURING THE PROCEDURE WHILE PREPARING THE CEMENT MIXTURE, THE MONOMER LIQUID WOULD NOT DISPENSE FROM THE POUCH. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186455 OPTIPAC 40 REFOBACIN REVISION BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A523B02130

    Patients

    Seq Age Sex Outcome Treatment
    1