BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 6016646 · Received October 11, 2016

    Report

    Report Number
    0001822565-2016-03652
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 6, 2016
    Report Date
    May 1, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    OQI
    PMA / PMN Number
    PK120370
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RECEIVED, NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: OQG. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED HAIR IN PACKAGING WAS RETURNED AND FROM THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE HAIR WAS THERE INSIDE PACKAGING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THIS ISSUE CAN BE ATTRIBUTED TO HUMAN FACTORS ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION CONFIRMS THE PRODUCT LIKELY LEFT ZIMMER BIOMET CONTROL NON-CONFORMING. BASED ON THE CONFIRMED PRESENCE OF A HAIR IN THE PACKAGE, IT WAS CONCLUDED THAT IT WAS DUE TO A MANUFACTURING DEFICIENCY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING THE IMPLANT DEBRIS WAS FOUND IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669140 VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER HIP PROSTHESIS OQI ZIMMER, INC. 63021245

    Patients

    Seq Age Sex Outcome Treatment
    1