BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 2904748 · Received December 4, 2012

    Report

    Report Number
    2249697-2012-02567
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MFR. ADD'L INFO INCLUDING X-RAYS AND MEDICAL RECORDS WAS NOT MADE AVAILABLE EITHER. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THR, WE HAD DIFFICULTY REMOVING THE ABOVE MENTIONED EXTENDED RANGE OF LINERS WITH NORMAL TECHNIQUE. THE CASE WAS COMPLETED AS ORIGINALLY PLANNED WITH A PROCEDURAL DELAY OF APPROX 30 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other