BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERAMIC LINER SHC

    MDR report key: 6088837 · Received November 9, 2016

    Report

    Report Number
    0002249697-2016-03540
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PER SALES REP, PATIENT HAD CERAMIC RIGHT HIP REVISED. PER SURGEON, THE LAST FEW WEEKS IT STARTED POPPING AND CLICKING. THERE WAS NO PAIN. THE SURGEON STATED THE LEFT HIP IS MAKING THE SAME NOISE AND THE PATIENT WILL BE REVISED AGAIN IN THE NEXT FEW WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740301 UNKNOWN CERAMIC LINER SHC HIP IMPLANT JDG STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R