BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMF STEM WITH STIKTITE SZ 5

    MDR report key: 4243455 · Received November 11, 2014

    Report

    Report Number
    8010764-2014-00054
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS GMBH
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILED LEFT THA, METAL ION DISEASE WITH POSSIBLE ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725337 SMF STEM WITH STIKTITE SZ 5 HIP IMPLANT JDH SMITH & NEPHEW ORTHOPAEDICS GMBH 10BTM0015A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR (B)(4)