BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22890417 · Received August 25, 2025

    Report

    Report Number
    2210968-2025-09778
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 20, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL INFORMATION: CITATION: HTTPS://DOI.ORG/10.7759/CUREUS.89280.

    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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    TITLE: WHEN SUTURES FAIL: EXTRUSION OF AN INSPIRE DEVICE AND A HIP PROSTHESIS IN THE SAME PATIENT THIS CASE REPORT DESCRIBES A 79-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED EXTRUSION OF BOTH A HIP PROSTHESIS AND AN INSPIRE HYPOGLOSSAL NERVE STIMULATOR (INSPIRE MEDICAL SYSTEMS, INC., MINNESOTA, USA), EACH EVENT ASSOCIATED WITH THE USE OF ETHIBOND (ETHICON, JOHNSON & JOHNSON, GEORGIA, USA) SUTURES. THE PATIENT HAD A HISTORY OF OBSTRUCTIVE SLEEP APNEA REFRACTORY TO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) THERAPY AND UNDERWENT INSPIRE DEVICE IMPLANTATION. POSTOPERATIVELY, THE PATIENT DEVELOPED A STERILE FLUID COLLECTION AND WOUND DEHISCENCE, LEADING TO VISIBLE EXTRUSION OF THE DEVICE. NOTABLY, THE PATIENT HAD PREVIOUSLY EXPERIENCED A NEAR EXTRUSION OF A HIP PROSTHESIS, ALSO LINKED TO ETHIBOND. IN BOTH CASES, THE INFECTIOUS WORKUP WAS NEGATIVE. FOLLOWING EXPLANTATION AND REIMPLANTATION OF THE INSPIRE DEVICE USING MONOCRYL AND PROLENE SUTURES (BOTH BY ETHICON, JOHNSON & JOHNSON, GEORGIA, USA) AND THE APPLICATION OF A DERMAL GRAFT, THE PATIENT ACHIEVED SUCCESSFUL HEALING WITHOUT RECURRENCE. REPORTED COMPLICATIONS ARE ETHIBOND (ETHICON, JOHNSON & JOHNSON, GEORGIA, USA) N=1 79-YEAR-OLD FEMALE PATIENT. STERILE FLUID COLLECTION TREATMENT: EXPLANTATION AND REIMPLANTATION OF THE INSPIRE DEVICE. WOUND DEHISCENCE TREATMENT: EXPLANTATION AND REIMPLANTATION OF THE INSPIRE DEVICE. VISIBLE EXTRUSION OF THE DEVICE TREATMENT: EXPLANTATION AND REIMPLANTATION OF THE INSPIRE DEVICE. NEAR EXTRUSION OF A HIP PROSTHESIS TREATMENT: NOT REPORTED. IN CONCLUSION, THIS CASE UNDERSCORES THE IMPORTANCE OF CONSIDERING SUTURE-RELATED FOREIGN BODY REACTIONS IN PATIENTS WITH RECURRENT IMPLANT EXTRUSION AND NO EVIDENCE OF INFECTION. SURGEONS SHOULD REMAIN VIGILANT IN SELECTING SUTURE MATERIALS, ESPECIALLY IN PATIENTS WITH A HISTORY OF ADVERSE REACTIONS, AND FUTURE RESEARCH SHOULD EXPLORE SUTURE-TISSUE INTERACTIONS TO GUIDE SAFER IMPLANT PRACTICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466554 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention