BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22422587 · Received July 7, 2025

    Report

    Report Number
    2210968-2025-07926
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    May 1, 2024
    Report Date
    July 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INTERNATIONAL JOURNAL OF LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL. 13, NO. 5, MAY 2024. (PUBMED CITATION NOT AVAILABLE)

    Description of Event or Problem · 0

    TITLE: COMPARISON OF PFNA AND PRIMARY HEMIARTHROPLASTY IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES IN THE ELDERLY: A RETROSPECTIVE STUDY. THIS RETROSPECTIVE COMPARATIVE STUDY AIMS TO EVALUATE THE OUTCOMES OF PFNA (PROXIMAL FEMORAL NAIL ANTIROTATION) VERSUS PRIMARY HEMIARTHROPLASTY IN TREATING UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES (IFF) IN THE ELDERLY POPULATION. BETWEEN JUNE 2021 AND JUNE 2023, A TOTAL OF 60 PATIENTS WITH UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES (IFF) (AO TYPE 31 A2 AND AO TYPE 31 A3) WHO WERE TREATED EITHER WITH PFNA (N = 30; 16 MALE AND 14 FEMALE; MEAN AGE WAS 72.4 PLUS OR MINUS 4.8 YEARS) OR CEMENTED HEMIARTHROPLASTY (N = 30; 15 MALE AND 15 FEMALE; MEAN AGE WAS 74.1 PLUS OR MINUS 5.2 YEARS) WERE INCLUDED IN THE STUDY. IN THE HEMIARTHROPLASTY GROUP, THE GREATER TROCHANTER FRAGMENT WAS REDUCED AND SUTURED WITH ETHIBOND SUTURES. THE FOLLOW-UP PERIOD WAS AT 3, 6, AND 12 MONTHS FOR CLINICAL AND RADIOLOGICAL EVALUATION. REPORTED COMPLICATIONS IN THE HEMIARTHROPLASTY GROUP INCLUDE INFECTION (N=2). IN CONCLUSION, THIS STUDY DEMONSTRATES THAT PFNA IS A SUPERIOR TREATMENT OPTION FOR UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES IN THE ELDERLY COMPARED TO PRIMARY HEMIARTHROPLASTY. PFNA IS ASSOCIATED WITH SHORTER OPERATING TIMES, LESS INTRA-OPERATIVE BLOOD LOSS, FEWER PERIOPERATIVE BLOOD TRANSFUSIONS, AND SHORTER HOSPITAL STAYS, LEADING TO QUICKER RECOVERY. ADDITIONALLY, PFNA PATIENTS EXHIBITED SIGNIFICANTLY BETTER FUNCTIONAL OUTCOMES AS MEASURED BY THE HHS AT VARIOUS FOLLOW-UP INTERVALS. DESPITE THESE ADVANTAGES, BOTH TREATMENT OPTIONS SHOULD BE CONSIDERED BASED ON INDIVIDUAL PATIENT CONDITIONS AND SURGICAL EXPERTISE TO ENSURE THE BEST OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177256 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other