BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 5050254 · Received September 2, 2015

    Report

    Report Number
    0002249697-2015-02916
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN HFX STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SURGEON REVISED PATIENT'S LEFT BIPOLAR HIP DUE TO PATIENT PRESENTING WITH PAIN. SURGEON REMOVED AN HFX STEM AND HEAD AND REPLACED WITH A RESTORATION MODULAR HIP SYSTEM. SURGEON COMMENTED INTRAOPERATIVELY THAT THE BIPOLAR SYSTEM SEEMED TO BE LOOSE UPON EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581150 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT HSB STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention