BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNITRAX C-TAPER SLEEVE -3MM

    MDR report key: 2974074 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00754
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K992570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE LISTED IN THIS REPORT IS DESCRIBED AS UNITRAX MODULAR ENDO HEAD, CAT # 6942-5-XXX, LOT # UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF EITHER OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A UNITRAX C-TAPER SLEEVE -3MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: RECORDS INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED STERILE LOT OR LOT IDS. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON HAD TO REMOVE A UNITREX HEAD AND SLEEVE BECAUSE, IT WAS INFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON HAD TO REMOVE A UNITREX HEAD AND SLEEVE BECAUSE IT WAS INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78917 UNITRAX C-TAPER SLEEVE -3MM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH 40963702

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| O| R