BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON CS INSERT #5 9MM

    MDR report key: 3002511 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00972
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT AS REPORTED WAS NOT CONFIRMED AS THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. DHR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. THE EXACT CAUSE OF THE REPORTED DETACHED LOCKING WIRE COULD NOT BE DETERMINED AS THE SUBJECT DEVICE WAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    WHEN INSERT WAS OPENED THE RETENTION WIRE WAS LOOSE IN THE PACKAGE. PRIMARY TOTAL KNEE SURGERY.

    Description of Event or Problem · 1

    WHEN INSERT WAS OPENED THE RETENTION WIRE WAS LOOSE IN THE PACKAGE. PRIMARY TOTAL KNEE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105674 X3 TRIATHLON CS INSERT #5 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCY601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other