BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM

    MDR report key: 15507595 · Received September 29, 2022

    Report

    Report Number
    0002249697-2022-01410
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 9, 2022
    Report Date
    September 29, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327027228
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 5521-B-400; TRI TS BASEPLATE SIZE 4; LOT# DUE7VA, CAT# UNKNOWN; TRIATHLON SIZE 3 PS FEMORAL COMPONENT; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AS REPORTED: "PT. PRESENTED WITH SYMPTOMS OF AN ACUTE KNEE-INFECTION. DR. HERNANDEZ OPTED TO EXPLANT ALL PREVIOUS IMPLANTS AND GIVE THE PATIENT A DYNAMIC ¿SPACER¿ WHICH WOULD ALLOW HER TO BEAR WEIGHT AND ACHIEVE GREATER FUNCTION THAN SHE WOULD WITH A STATIC-SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922236 NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5537-G-411 6J5AT7 07613327027228

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R