BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARRIS HIP HEAD

    MDR report key: 898502 · Received August 15, 2007

    Report

    Report Number
    2249697-2007-00118
    Event Type
    Injury
    Date Received
    August 15, 2007
    Date of Event
    January 10, 2007
    Report Date
    July 12, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAY
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, THE HEAD WOULD NOT COME OFF OF THE STEM. THIS RESULTED IN A TWO MONTH HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARRIS HIP HEAD IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention