BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON #4 CS ALLPOLY 16MM

    MDR report key: 15301127 · Received August 26, 2022

    Report

    Report Number
    0002249697-2022-01246
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    October 18, 2021
    Report Date
    August 26, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327043280
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON CR FEM COMP #4 L-CEM; CAT # 5510F401; LOT # LAB6C. 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

    THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. THE PATIENT DEVELOPED PJI IN THE LEFT KNEE AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED WITH ALL COMPONENTS EXCHANGED ON (B)(6), 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164527 TRIATHLON #4 CS ALLPOLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5534-A-416 487035 07613327043280

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| H