BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG X3 INSERT 36MM ID

    MDR report key: 2690668 · Received August 7, 2012

    Report

    Report Number
    2249697-2012-01107
    Event Type
    Injury
    Date Received
    August 7, 2012
    Date of Event
    July 13, 2012
    Report Date
    July 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELTA C-TAPER HEAD 36MM +0, CAT# 18-3600, LOT# 537495 WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IS ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION. AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THEY WERE RETAINED BY THE PT AND WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DUE TO THE CONCERN OF INFECTION DR (B)(6) BROUGHT THE PT TO THE OPERATING ROOM AND DECIDED TO REPLACE THE LINER AND HEAD LISTED ABOVE WITH NEW IMPLANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG X3 INSERT 36MM ID IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MLE2HT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention