BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER STEM

    MDR report key: 5149728 · Received October 14, 2015

    Report

    Report Number
    1822565-2015-02148
    Event Type
    Injury
    Date Received
    October 14, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE PART AND LOT NUMBERS OF THE DEVICES ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS, COMPLAINT HISTORY COULD NOT BE REVIEWED. THE REPORTED DEVICES ARE USED FOR TREATMENT. IT COULD NOT BE CONFIRMED IF THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICES CAUSED OR CONTRIBUTED TO PATIENT INFECTION.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS11999-013-3167-4/FULLTEXT.HTML (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT IN 5 PATIENTS THE STEM WAS REMOVED FOR DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680401 UNKNOWN ZIMMER STEM HIP PROSTHESIS KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention