BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON #4 CS ALLPOLY 16MM

    MDR report key: 12808412 · Received November 14, 2021

    Report

    Report Number
    0002249697-2021-01882
    Event Type
    Injury
    Date Received
    November 14, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 25, 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. 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# 5510F401; TRIATHLON CR FEM COMP #4 L-CEM; LOT# J2N7H. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    CORRECTION: MFR REPORT #0002249697-2021-01882 WAS REPORTED IN ERROR. THIS PI REPORTS THE REMOVAL OF A TEMPORARY SPACER (STAGE 2). THE REVISION FOR INFECTION INVOLVED DEVICES OF AN UNKNOWN MANUFACTURER. INSUFFICIENT INFORMATION WAS PROVIDED AND NO ADDITIONAL INFORMATION IS AVAILABLE, THEREFORE, THIS COMPLAINT IS BEING CANCELED.

    Description of Event or Problem · 0

    PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE (B)(6) 2011). HAD A PJI OF BOTH KNEES. UNDERGOES REVISION ON (B)(6) 2020 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC CEMENT LOADED FOR TREATMENT. PATIENT RETURNS FOR A LEFT PJI KNEE REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED.

    Description of Event or Problem · 0

    CORRECTION: THIS EVENT WAS REPORTED IN ERROR. THIS PI REPORTS THE REMOVAL OF A TEMPORARY SPACER (STAGE 2). THE REVISION FOR INFECTION INVOLVED DEVICES OF AN UNKNOWN MANUFACTURER. INSUFFICIENT INFORMATION WAS PROVIDED AND NO ADDITIONAL INFORMATION IS AVAILABLE, THEREFORE, THIS COMPLAINT IS BEING CANCELED. PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE (B)(6), 2011). HAD A PJI OF BOTH KNEES. UNDERGOES REVISION ON (B)(6), 2020 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC CEMENT LOADED FOR TREATMENT. PATIENT RETURNS FOR A LEFT PJI KNEE REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706711 TRIATHLON #4 CS ALLPOLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5534-A-416 462228 07613327043280

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention| O| H