BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM BPLATE TRIATHLON S1

    MDR report key: 19111548 · Received April 15, 2024

    Report

    Report Number
    0002249697-2024-00600
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 15, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327041477
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING MALPOSITION INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED VIA MEDICAL REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED. CLINICIAN REVIEW: -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "THE ADDITIONAL RADIOGRAPHS CONFIRM THAT THE FEMORAL IMPLANT IS AT THE VERY LEAST HYPER FLEXED, OUT OF THE RANGE OF ACCEPTABILITY. IT MAY WELL BE OVERSIZED AS WELL WHICH CAN ONLY BE DETERMINED USING DIGITAL OR ACETATE TEMPLATES. THE TIBIAL IMPLANT IS ALSO HYPER FLEXED WITH SOME POSTERIOR OVERHANG. IN MY OPINION, COUPLING THE HYPER FLEXION OF THE FEMORAL COMPONENT WITH AN UNRESURFACED PATELLA, THAT CERTAINLY CAN CAUSE IMPINGEMENT WITH PAIN AND STIFFNESS THAT CAN RESULT IN THE NEED FOR REVISION SURGERY, POSSIBLY OF ALL COMPONENTS WITH MOST LIKELY RESURFACING OF THE PATELLA. I WOULD CONSIDER THIS AN IATROGENIC SITUATION." -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: PATIENT REPORTED LEFT KNEE PAIN AND NOTED PRODUCT IS "TOO LARGE". A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "THE ADDITIONAL RADIOGRAPHS CONFIRM THAT THE FEMORAL IMPLANT IS AT THE VERY LEAST HYPER FLEXED, OUT OF THE RANGE OF ACCEPTABILITY. IT MAY WELL BE OVERSIZED AS WELL WHICH CAN ONLY BE DETERMINED USING DIGITAL OR ACETATE TEMPLATES. THE TIBIAL IMPLANT IS ALSO HYPER FLEXED WITH SOME POSTERIOR OVERHANG. IN MY OPINION, COUPLING THE HYPER FLEXION OF THE FEMORAL COMPONENT WITH AN UNRESURFACED PATELLA, THAT CERTAINLY CAN CAUSE IMPINGEMENT WITH PAIN AND STIFFNESS THAT CAN RESULT IN THE NEED FOR REVISION SURGERY, POSSIBLY OF ALL COMPONENTS WITH MOST LIKELY RESURFACING OF THE PATELLA. I WOULD CONSIDER THIS AN IATROGENIC SITUATION." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE AFTER REVISION SURGERY TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT KNEE PAIN AND NOTED PRODUCT IS "TOO LARGE". PATIENT IS SCHEDULED FOR A REVISION ON MARCH 21ST. AS PER MEDICAL REVIEW: "THE ADDITIONAL RADIOGRAPHS CONFIRM THAT THE FEMORAL IMPLANT IS AT THE VERY LEAST HYPER FLEXED, OUT OF THE RANGE OF ACCEPTABILITY. IT MAY WELL BE OVERSIZED AS WELL WHICH CAN ONLY BE DETERMINED USING DIGITAL OR ACETATE TEMPLATES. THE TIBIAL IMPLANT IS ALSO HYPER FLEXED WITH SOME POSTERIOR OVERHANG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683168 TRITANIUM BPLATE TRIATHLON S1 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH CTD86812 07613327041477

    Patients

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