BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON P/A CR BEADED #2L

    MDR report key: 18921744 · Received March 18, 2024

    Report

    Report Number
    0002249697-2024-00432
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 15, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327040906
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING MALPOSITION INVOLVING A TRIATHLON FEMORAL COMPONENT 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: 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.

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. H3 OTHER TEXT : DEVICE IS STILL IMPLANTED.

    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."

    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: X-RAYS REVEALED "WITHIN FOUR MONTHS THE PATIENT WAS COMPLAINING OF PAIN AND STIFFNESS AND WENT FOR SECOND OPINIONS WHO FELT HER FEMORAL COMPONENT COULD BE TOO LARGE CAUSING STUFFING OF THE JOINT. THE PATIENT APPARENTLY IS SCHEDULED FOR REVISION SURGERY. ONLY A SINGLE AP VIEW OF THE KNEE WAS PROVIDED TO ME SO I CANNOT ADEQUATELY ASSESS SIZING WITH CERTAINTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213353 TRIATHLON P/A CR BEADED #2L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH NYX2C1 07613327040906

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other| H