BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL

    MDR report key: 23794609 · Received December 12, 2025

    Report

    Report Number
    1020279-2025-02061
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 10, 2023
    Report Date
    December 12, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). MCALEESE T, MCLEOD A, KEOGH C, HARTY JA. MECHANICAL OUTCOMES OF THE TFNA, INTERTAN AND IMHS INTRAMEDULLARY NAILING SYSTEMS FOR THE FIXATION OF PROXIMAL FEMUR FRACTURES. INJURY. 2024 FEB;55(2):111185. DOI: 10.1016/J.INJURY.2023.111185. EPUB 2023 NOV 10. PMID: 38070327. THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "MECHANICAL OUTCOMES OF THE TFNA, INTERTAN AND IMHS INTRAMEDULLARY NAILING SYSTEMS FOR THE FIXATION OF PROXIMAL FEMUR FRACTURES", ONE (1) PATIENT THAT INITIALLY UNDERWENT INTERNAL FIXATION SURGERY WITH AN INTERTAN SYSTEM FROM 2012 TO 2017, TO TREAT A PROXIMAL FEMUR FRACTURE, SUSTAINED A PERIPROSTHETIC FRACTURE. THE MEASURES TAKEN TO RESOLVE THIS EVENT, IF ANY, ARE NOT KNOWN AT THIS TIME. PATIENT OUTCOME IS NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761086 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other