BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL

    MDR report key: 14053421 · Received April 8, 2022

    Report

    Report Number
    1020279-2022-01548
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    January 18, 2021
    Report Date
    May 10, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). "COMPARISON OF CLOSED AND LIMITED-OPEN INTRAMEDULLARY NAILS FOR FEMORAL SUBTROCHANTERIC FRACTURES." DOI: 1005-8478 (2021) 20-1893-04.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; HOWEVER, PER THE ARTICLE, THE CUT OUT WAS DUE TO PREMATURE WEIGHT-BEARING. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO BONE DEGENERATION, LACK OF INGROWTH, SURGICAL TECHNIQUE, SIZE OF DEVICE, PATIENT ANATOMY, ABNORMAL LOADING AND/OR TRAUMATIC INJURY. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "COMPARISON OF CLOSED AND LIMITED-OPEN INTRAMEDULLARY NAILS FOR FEMORAL SUBTROCHANTERIC FRACTURES ", 1 PATIENT SUFFERED OF INTERNAL FIXATION CUT OUT DUE TO PREMATURE WEIGHT-BEARING. THIS EVENT WAS TREATED WITH A REVISION SURGERY OF JOINT PROSTHESIS REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827825 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention