BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION 8" HA HIP STEM

    MDR report key: 1872121 · Received October 8, 2010

    Report

    Report Number
    2249697-2010-01328
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K944836
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEM FRACTURED. STEM FRACTURED AT PROXIMAL THIRD POINT OF STEM. PT WAS OPERATED ON TO REMOVE FRACTURED STEM. THERE WAS NOT ENOUGH BONE TO SUPPORT RESTORATION MODULAR COMPONENT SO A TEMPORARY SPACER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION 8" HA HIP STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R