BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 24691313 · Received March 25, 2026

    Report

    Report Number
    2210968-2026-03090
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    October 13, 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
    KS
    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: ARCH ORTHOP TRAUMA SURG. 2025 OCT 13;145(1):468. HTTPS://DOI.ORG/10.1007/S00402-025-06084-4. PMID: 41081919.

    Description of Event or Problem · 0

    TITLE:. RESECTION ARTHROPLASTY FOR DEEP SHOULDER INFECTION IN A NATIVE SHOULDER WITH AN INTACT ROTATOR CUFF: A SALVAGE OPTION WHEN REVERSE SHOULDER ARTHROPLASTY IS NOT FEASIBLE. THIS STUDY AIMS TO EVALUATE THE MID-TERM RESULTS OF RESECTION ARTHROPLASTY IN NATIVE SHOULDERS WITH INTACT ROTATOR CUFF TENDONS. BETWEEN 2001 AND 2025, 69 PATIENTS UNDERWENT SURGERY FOR DEEP SHOULDER INFECTION USING NO. 2 ETHIBOND SUTURE (ETHICON INC, SOMERVILLE, NJ, USA). REPORTED COMPLICATIONS ARE: ETHIBOND (N=1) CASE 6: REQUIRED ADDITIONAL SURGERY TO TREAT PERSISTENT INFECTION AFTER RESECTION ARTHROPLASTY TREATMENT: ADDITIONAL SURGERY, OPEN IRRIGATION AND DEBRIDEMENT. IN CONCLUSION, RESECTION ARTHROPLASTY IN NATIVE SHOULDERS WITH PRESERVED ROTATOR CUFF TENDONS ACHIEVED RELIABLE INFECTION CONTROL, SUBSTANTIAL PAIN RELIEF, AND FUNCTIONAL IMPROVEMENT SUPERIOR TO MOST HISTORICAL SERIES. THE FAVORABLE OUTCOMES APPEAR TO BE ATTRIBUTABLE TO PRESERVED ROTATOR CUFF BIOMECHANICS, WHICH PROVIDE RESIDUAL STABILITY AND ALLOW REHABILITATION. HOW EVER, RESECTION ARTHROPLASTY REMAINS AN ULTIMA RATIOPROCE DURE FOR CASES IN WHICH REVERSE SHOULDER ARTHROPLASTY IS NOT FEASIBLE, RATHER THAN AN EQUIVALENT ALTERNATIVE TO PROSTHETIC RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748242 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention