BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3110138 · Received May 13, 2013

    Report

    Report Number
    0002249697-2013-01661
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TRIATHLON PS INSERT EXPLANT. INSERT WILL NOT FULLY SEAT POSTERIOR ON UNIVERSAL BASEPLATE. NEW LINER WAS SELECTED AND INSERTED INTO BASEPLATE WITHOUT A PROBLEM.

    Description of Event or Problem · 1

    TRIATHLON PS INSERT EXPLANT. INSERT WILL NOT FULLY SEAT POSTERIOR ON UNIVERSAL BASEPLATE. NEW LINER WAS SELECTED AND INSERTED INTO BASEPLATE WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211589 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MJMX2P

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other