BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMALL FEMORAL COMPONENT MK 3 SMFC01

    MDR report key: 23392477 · Received October 27, 2025

    Report

    Report Number
    0002249697-2025-01183
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    May 3, 2010
    Report Date
    December 18, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A PATIENT SPECIFIC, PROXIMAL TIBIA, FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED VIA CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "PI WAS CREATED FOR THE OPEN REDUCTION AND INTERNAL FIXATION OF THE FEMORAL FRACTURE PERFORMED IN 2011. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF PERIPROSTHETIC FRACTURE ARE MULTI FACTORIAL INCLUDING THE POSSIBILITY OF SURGICAL TECHNIQUE IF THERE WAS ANY BREACH OF THE CORTEX IN ONE WAY OR ANOTHER, PATIENT FACTORS INCLUDING ACTIVITY LEVEL LIFESTYLE AND BMI AS WELL AS THE POSSIBILITY OF TRAUMA. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF FOR THIS EVENT." PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE OF THE FEMUR. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "PI WAS CREATED FOR THE OPEN REDUCTION AND INTERNAL FIXATION OF THE FEMORAL FRACTURE PERFORMED IN 2011. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF PERIPROSTHETIC FRACTURE ARE MULTI FACTORIAL INCLUDING THE POSSIBILITY OF SURGICAL TECHNIQUE IF THERE WAS ANY BREACH OF THE CORTEX IN ONE WAY OR ANOTHER, PATIENT FACTORS INCLUDING ACTIVITY LEVEL LIFESTYLE AND BMI AS WELL AS THE POSSIBILITY OF TRAUMA. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF FOR THIS EVENT." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ORIF PERFORMED IN 2011. AS REPORTED: SURGEON HAS REQUESTED A PATIENT SPECIFIC LEFT DISTAL FEMORAL REPLACEMENT FOR THE FOLLOWING PATIENT. THE REQUEST IS TO RETAIN THE PATIENT SPECIFIC PROXIMAL TIBIAL COMPONENT IN SITU AND REVISE THE FEMORAL ONE. PATIENT HISTORY: PREVIOUS PROXIMAL TIBIAL REPLACEMENT (UNCEMENTED) FOR OSTEOSARCOMA. ROTATING HINGE KNEE. PERIPROSTHETIC FEMORAL FRACTURE 2011 - ORIF PLATE AND SCREWS. PROXIMAL TIBIAL REPLACEMENT WELL FIXED. DISTAL FEMUR UNCEMENTED COMPONENT LOOSE. PLAN TO REVISE TO A SHORT BODY DFR WITH A CEMENTED STEM. PLAN TO LEAVE PROXIMAL TIBIA AND REVISE DISTAL FEMUR COMPONENT TO A NEW CEMENTED DISTAL FEMUR PLUS BUSHING CHANGE, IDEALLY LEAVE FEMORAL PLATE AND SCREWS IN SITU AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308419 UNKNOWN SMALL FEMORAL COMPONENT MK 3 SMFC01 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH PIN 10066

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention| H