BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 17894140 · Received October 9, 2023

    Report

    Report Number
    0002249697-2023-01160
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    July 18, 2023
    Report Date
    January 10, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327382846
    PMA / PMN Number
    K172634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING WEAR INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE DEVICE IS DAMAGED/DEFORMED IN THE AREA OF THE LOCKING MECHANISM. DAMAGE OBSERVED ON THE SURFACE OF THE INSERT CONSISTENT WITH EXPLANTATION. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE DEVICE IS DAMAGED/DEFORMED IN THE AREA OF THE LOCKING MECHANISM. DAMAGE OBSERVED ON THE SURFACE OF THE INSERT CONSISTENT WITH EXPLANTATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    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 SIMILAR EVENTS FOR THE LOT REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    RE-OPR DUE TO COMPLICATIONS WITH WOUND CLOSURE. ADDITIONAL INFORMATION: UNDER THE OPR SURGEON FOUND SCRATCH MARKS ON THE SURFACE OF THE INSERT.

    Description of Event or Problem · 0

    RE-OPR DUE TO COMPLICATIONS WITH WOUND CLOSURE. ADDITIONAL INFORMATION: UNDER THE OPR SURGEON FOUND SCRATCH MARKS ON THE SURFACE OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120621 TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 4A35JR 07613327382846

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Prefer Not To Disclose Required Intervention| H