BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM

    MDR report key: 3875133 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02293
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN LINER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    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 WAS NOT PERFORMED AS NO PRODUCT SPECIFIC MODES WERE IDENTIFIED. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT KNEE REVISED FOR RETINACULUM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT KNEE REVISED FOR RETINACULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352234 NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH MKM2TY

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention