BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 24690903 · Received March 25, 2026

    Report

    Report Number
    2210968-2026-03068
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 25, 2026
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. 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: ARTHROPLAST TODAY. 2025 DEC 30;37:101935. HTTPS://DOI.ORG/10.1016/J.ARTD.2025.101935 PMID: 41551271; PMCID: PMC12803931.

    Description of Event or Problem · 0

    TITLE: STABILIZING THE UNSTABLE: CONE HEMIARTHROPLASTY IN GERIATRIC INTERTROCHANTERIC FRACTURES. THIS RETROSPECTIVE ANALYSIS STUDY EVALUATES SHORT-TERM OUTCOMES OF BIPOLAR HEMIARTHROPLASTY USING AN UNCEMENTED TITANIUM FLUTED, TAPERED CONE FEMORAL PROSTHESIS IN SUCH FRACTURES. BETWEEN JUNE 2023 AND JULY 2024, 43 CONSECUTIVE ELDERLY PATIENTS COMPRISING 11 MALES (25%) AND 32 FEMALES (75%), WITH A MEAN AGE OF 83.6 YEARS (RANGE, 70¿106) TREATED WITH UNCEMENTED BIPOLAR HEMIARTHROPLASTY USING A TAPERED, FLUTED CONE STEM. GREATER TROCHANTERIC FRAGMENTS WERE PRIMARILY FIXED WITH NONABSORBABLE SUTURES (ETHIBOND). GT FIXATION WAS PERFORMED USING ETHIBOND SUTURES IN 39 PATIENTS (90.7%). OF THE 43 PATIENTS OPERATED ON, 40 COMPLETED A MINIMUM OF 12 MONTHS FOLLOW-UP. REPORTED COMPLICATIONS: ETHIBOND SUTURES (ETHICON): (N=1) PATIENT DEMONSTRATED PERSISTENT GT NONUNION WITH ASSOCIATED ABDUCTOR INSUFFICIENCY, WHICH CONTRIBUTED TO AN EARLY POSTOPERATIVE DISLOCATION. TREATMENT: MANAGED SURGICALLY WITH NO RECURRENCE. (N=1) PATIENT (2.3%) DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION, TREATMENT: WHICH RESOLVED WITH WOUND WASH, DEBRIDEMENT, AND INTRAVENOUS ANTIBIOTICS. IN CONCLUSION, BIPOLAR HEMIARTHROPLASTY USING AN UNCEMENTED TAPERED CONE FEMORAL PROSTHESIS IS A RELIABLE AND EFFECTIVE OPTION FOR MANAGING UNSTABLE INTERTROCHANTERIC FRACTURES IN THE ELDERLY. THE IMPLANT OFFERS STABLE FIXATION EVEN IN OSTEOPOROTIC BONE, FACILITATES EARLY MOBILIZATION, AND DEMONSTRATES FAVORABLE SHORT-TERM FUNCTIONAL OUTCOMES WITH MINIMAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749186 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention