BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL

    MDR report key: 14061604 · Received April 8, 2022

    Report

    Report Number
    1020279-2022-01695
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    May 1, 2021
    Report Date
    May 6, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    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). POSTOPERATIVE COMPLICATIONS AND LONG-TERM EFFECTS OF THREE TYPES OF OPERATION ON UNSTABLE INTERTROCHANTERIC FRACTURE OF FEMUR IN THE ELDERLY. CHINESE JOURNAL OF GERONTOLOGY. FENG HAO, ZHANG BIN, NIE TAO (DEPARTMENT OF ORTHOPEADICS, YINGTAN PEOPLE'S HOSPITAL, YINGTAN 335000, CHINA). DOI: 10.3969/J.ISSN.1005-9202.2021.09.019.

    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, PER SUBSEQUENT E-MAIL, NO FURTHER INFORMATION WILL BE PROVIDED. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE BUT NOT LIMITED TO PROCEDURAL/USER ERROR, SURGICAL COMPLICATION OR PATIENT CONDITION. 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 "POSTOPERATIVE COMPLICATIONS AND LONG-TERM EFFECTS OF THREE TYPES OF OPERATION ON UNSTABLE INTERTROCHANTERIC FRACTURE OF FEMUR IN THE ELDERLY", 1 PATIENT WHO INITIALLY UNDERWENT PRIMARY IMPLANTATION OF A TRIGEN INTERTAN NAIL TO TREAT AN INTERTROCHANTERIC FRACTURE EXPERIENCED COXA VARA. NO SPECIFIC DETAILS WERE PROVIDED ON HOW WAS THIS OUTCOME TREATED OR RESOLVED. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187596 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other