BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINECTIV MODULAR NECK

    MDR report key: 5530076 · Received March 28, 2016

    Report

    Report Number
    1822565-2016-00793
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    February 9, 2016
    Report Date
    November 8, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    KWA
    PMA / PMN Number
    PK063251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #00801803202, VERSYS FEMORAL HEAD, LOT #61187193 MANUFACTURED BY B.V. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A PHOTOGRAPH OF THE EXPLANTED HEAD AND NECK WAS PROVIDED; HOWEVER TAPER CORROSION COULD NOT BE CONFIRMED AS THE NECK REMAINS ATTACHED TO THE HEAD. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO PAIN, ELEVATED COBALT AND CHROMIUM LEVELS, AND SUSPECTED TRUNNIONOSIS OF THE FEMORAL NECK AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184972 KINECTIV MODULAR NECK KWA KWA ZIMMER INC 60841364

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention