BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0° INSERT TRIAL 36MM

    MDR report key: 2974572 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00760
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    FDA1E
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN 36 ZERO DEGREE E LINER TRIAL (GRAY). WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TRIDENT INSERT TRIAL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION CANNOT CONFIRM THE EVENT. NO DEVICE PROBLEM WAS FOUND. A MATERIAL ANALYSIS FOUND NO PROBLEM WITH THE RETURNED PRODUCT. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE RETURNED DEVICE SHOWS NO EVIDENCE OF A BROKEN SCREW. THE DEVICE IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A RIGHT PRIMARY TOTAL HIP ON PATIENT AND WHEN SURGEON WAS REMOVING THE 36 ZERO DEGREE E LINER TRIAL, THE SCREW CONNECTION BROKE OFF OF THE TRIAL. NO DELAY OR ADVERSE CONSEQUENCE TO PATIENT AS TRIAL WAS REMOVED AND CASE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A RIGHT PRIMARY TOTAL HIP ON PATIENT AND WHEN SURGEON WAS REMOVING THE 36 ZERO DEGREE E LINER TRIAL, THE SCREW CONNECTION BROKE OFF OF THE TRIAL. NO DELAY OR ADVERSE CONSEQUENCE TO PATIENT AS TRIAL WAS REMOVED AND CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78705 TRIDENT 0° INSERT TRIAL 36MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SS109264

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other