BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNITRAX MODULAR ENDO HEAD 52MM

    MDR report key: 2831062 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02197
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K014226
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT LATER TIME, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT'S HEMIARTHROPLASTY THAT WAS PERFORMED DUE TO HIP FRACTURE WAS REVISED TO A RESTORATION MODULAR STEM WITH A TRITANIUM SHELL AND MDM LINER. HEMI WAS REVISED DUE TO LOOSENING AND OSTEOLYSIS AND CEMENT BONE INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNITRAX MODULAR ENDO HEAD 52MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA A04S459

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention