BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METASUL FEMORAL HEAD

    MDR report key: 6967920 · Received October 23, 2017

    Report

    Report Number
    0009613350-2017-01482
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    March 2, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 14, 2018. IT WAS DISCOVERED THAT ZIMMER BIOMET ACCIDENTALLY CREATED TWO NOTIFICATIONS FOR THE SAME PATIENT. THE SAME EVENT DETAILS AND PRODUCTS WERE REPORTED TWICE. THIS CASE IS A DUPLICATE FROM THE ORIGINAL CASE (B)(4) WITH MANUFACTURER REPORT NUMBER 0009613350-2017-01490. PLEASE INVALIDATE THIS CASE FROM YOUR SYSTEM. ZIMMER (B)(4) WILL INVALIDATE THIS CASE FROM THE SYSTEM. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN METASUL FEMORAL HEAD IMPLANTED ON AN UNKNOWN DATE ON THE RIGHT SIDE AND IT WAS REVISED ON AN UNKNOWN DATE DUE TO ELEVATED METAL ION LEVELS AND SUSPECTED PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750182 UNKNOWN METASUL FEMORAL HEAD UNKNOWN KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R