BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3120739 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01728
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN LINER. THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN STEM, UNKNOWN HEAD, UNKNOWN CUP. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 0° X3 INSERT 36MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT OR STERILE LOT. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. 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 REVISED PATIENT'S LEFT HIP DUE TO INFECTION. SURGEON REMOVED ALL IMPLANTS AND IMPLANTED ANTIBIOTIC SPACER. PREVIOUSLY REPORTED REJUVENATE REVISION AND NOW THIS REVISION FOR INFECTION AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT HIP DUE TO INFECTION. SURGEON REMOVED ALL IMPLANTS AND IMPLANTED ANTIBIOTIC SPACER. PREVIOUSLY REPORTED REJUVENATE REVISION AND NOW THIS REVISION FOR INFECTION AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221856 TRIDENT 0° X3 INSERT 36MM ID IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MMAVA3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention