BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3023690 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01089
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    AN EVENT REGARDING A SEATING ISSUE INVOLVING A TRIATHLON PS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. -COMPLAINT HISTORY REVIEW: CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE ARE NO OTHER SIMILAR EVENTS REPORTED. CONCLUSIONS: THE REPORTED EVENT CANNOT BE CONFIRMED WITHOUT EVALUATION OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    THE PS INSERT HAD THE LOCKING RING DISENGAGE DURING IMPLANTATION. A BACKUP WAS USED.

    Description of Event or Problem · 1

    THE PS INSERT HAD THE LOCKING RING DISENGAGE DURING IMPLANTATION. A BACKUP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125487 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKL194

    Patients

    Seq Age Sex Outcome Treatment
    1 Other