BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM BPLATE TRIATHLON S6

    MDR report key: 3852150 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02124
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION DUE TO PAIN INVOLVING A TRITANIUM BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION A TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A #6 TRIATHLON TRITANIUM TIBIAL BASEPLATE IN A PREVIOUS SURGERY. THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR REMOVED THE BASEPLATE AND REPLACED IT WITH A TRIATHLON UNIVERSAL BASEPLATE #6 (5521-B-600).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A #6 TRIATHLON TRITANIUM TIBIAL BASEPLATE IN A PREVIOUS SURGERY. THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR REMOVED THE BASEPLATE AND REPLACED IT WITH A TRIATHLON UNIVERSAL BASEPLATE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329797 TRITANIUM BPLATE TRIATHLON S6 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH EDJPR

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention