BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD ADAPTER M/0; 12/14-18/20

    MDR report key: 2091425 · Received May 4, 2011

    Report

    Report Number
    9613350-2011-00291
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 10, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE EXPLANTED HEAD ADAPTER WILL BE RETURNED FOR EVALUATION. AS SOON AS WE HAVE ADDITIONAL INFORMATION OR THE INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MDR REPORT WILL BE FILED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DUROM HAS BEEN IMPLANTED IN 2006. PATIENT HAD PAIN FROM THE START AND EVENTUALLY IMPLANT HAS BEEN REMOVED. WITH EXPLANTATION, APPROX 500 ML OF CLEAR HUMAN FLUID HAS BEEN EXPOSED. DUROM ADAPTOR SHOWS 2 DARK RINGS AT THE INSIDE AND DEBRIS WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD ADAPTER M/0; 12/14-18/20 DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2342206

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization