BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER VERSYS ADVOCATE FEMORAL STEM

    MDR report key: 6016670 · Received October 11, 2016

    Report

    Report Number
    0002648920-2016-03211
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    January 8, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LZO
    PMA / PMN Number
    PK950312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED AS THE PRODUCT WAS RETURNED AND EXAMINED. THE CENTRALIZER WAS FRACTURED INTO TWO PIECES AND THE FRACTURE OCCURRED ALONG THE AXIS OF SYMMETRY. THIS CAN BE OBSERVED IN THE ATTACHED PHOTOS. THE REMAINDER OF FEMORAL STEM PART # 00785001300 WAS NOT RETURNED. THE PRODUCT WAS MANUFACTURED IN AUG 2016 AND THE EVENT OCCURRED IN (B)(6) 2016, SO THE PRODUCT WAS DAMAGED WITHIN A MONTH OF TRANSIT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET IS CANNOT BE DETERMINED AS THERE IS NO ENOUGH EVIDENCE TO SHOW THAT CENTRALIZERS WERE PACKAGED EXHIBITING DAMAGE FROM ZMBV. 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 THE STEM WAS FOUND BROKEN PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669137 ZIMMER VERSYS ADVOCATE FEMORAL STEM HIP PROSTHESIS LZO ZIMMER MANUFACTURING B.V. 63446748

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR