BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL STEM INSERTER

    MDR report key: 2823915 · Received October 10, 2012

    Report

    Report Number
    2249697-2012-01837
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING REVISION OF A COMPETITOR COMPONENT, RESTORATION MODULAR DISTAL STEM INSERTER IT WOULD NOT SCREW DOWN PROPERLY ONTO THE STEM AND JUST KEPT ROTATING W/O HOLDING THE STEM FIRMLY. ANOTHER ITEM WAS USED INSTEAD AND CASE COMPLETED AS ORIGINALLY PLANNED WITH 15 MINS DELAY BUT NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL STEM INSERTER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACDB4C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other