BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    KLASSIC BLADE OFFSET FEMORAL STEM, POROUS, SIZE 6

    MDR report key: 24449125 · Received February 25, 2026

    Report

    Report Number
    3008544874-2026-00002
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 11, 2026
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    LPH
    UDI-DI
    00814703012341
    PMA / PMN Number
    K151440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED FEEDBACK FROM BOTH THE SURGEON AND THE SALES REP REGARDING THIS REVISION CASE. BOTH COMMENTED ON THE AGE OF THE PATIENT COMBINED WITH THE POOR BONE QUALITY DUE TO OSTEOPOROSIS AND TYPE C FEMUR AS BEING THE MAIN CONTRIBUTING FACTORS TO THE SPONTANEOUS FRACTURE IN THIS CASE. THIS IS THE FIRST REPORTED INCIDENT OF A NON-FALL RELATED FEMUR FRACTURE WITH ANY TJO STEMS. THERE ARE NO DEVIATIONS OR NMRS FOR THE FEMUR LOT THAT WOULD IDENTIFY ANYTHING ABNORMAL ABOUT THE FEMUR USED IN THE PRIMARY CASE. THEREFORE, THERE IS NO CONCLUSIVE FINDING RELATED TO THE STEM ITSELF OR THE PROCEDURE, THE LIKELY CAUSE IS PATIENT RELATED DUE TO POOR BONE QUALITY.

    Description of Event or Problem · 0

    A SERIOUS INJURY RESULTED IN THE NEED FOR SURGICAL INTERVENTION DUE TO A SPONTANEOUS VANCOUVER TYPE B2 FRACTURE WITH STEM SUBSIDENCE 10 DAYS AFTER THE PRIMARY THA SURGERY WITH NO REPORTED FALL OR INCIDENT BY THE PATIENT. SURGEON REPORTED THE PATIENT WAS VERY OSTEOPOROTIC WITH A TYPE C FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443090 KLASSIC BLADE OFFSET FEMORAL STEM, POROUS, SIZE 6 KNEE FEMORAL IMPLANT LPH TOTAL JOINT ORTHOPEDICS, INC. M231130-6 00814703012341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R