BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM SPLINED STEM 9X120MM

    MDR report key: 22185652 · Received June 11, 2025

    Report

    Report Number
    0001825034-2025-01697
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 25, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304674547
    PMA / PMN Number
    K141331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. VISUAL EVALUATION OF PICTURES PROVIDED IDENTIFIED EXPLANTED FEMORAL COMPONENTS AND BOTH THE PATIENT'S FEMUR AND THE FEMORAL STEM HAD FRACTURED. RADIOGRAPHIC REVIEW CONFIRMED FRACTURE OF THE PROXIMAL RIGHT FEMUR AND RIGHT FEMORAL STEM. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM FINN MODULAR PROXIMAL FEMORAL COMPONENT RIGHT 7CM CATALOG #: 150457 LOT #: 075970, BIOMET MODULAR HEAD 28X6MM CATALOG #: 163660 LOT #: 64895971, RINGLOC BI-POLAR ACETABULAR CUP 28X46MM CATALOG #: 11-165216 LOT #: 336230 H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY REVISION OF THE FEMORAL COMPONENTS TO ADDRESS POST-OPERATIVE FEMORAL STEM FRACTURE AND PERIPROSTHETIC FEMUR FRACTURE AFTER A FALL. IT IS UNKNOWN WHETHER THE FRACTURES OCCURRED DUE TO THE FALL OR WHETHER THE PATIENT EXPERIENCED THE FRACTURES AND RESULTED IN FALLING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86568 ORTHOPEDIC SALVAGE SYSTEM SPLINED STEM 9X120MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 519910 00880304674547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE