BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 24578630 · Received March 12, 2026

    Report

    Report Number
    2210968-2026-02525
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    August 16, 2025
    Report Date
    March 12, 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: CUREUS. 2025 AUG 16;17(8):E90255. HTTPS://DOI.ORG/10.7759/CUREUS.90255 PMID: 40964547; PMCID: PMC12436082.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF FUNCTIONAL OUTCOMES OF CEMENTED BIPOLAR HEMIARTHROPLASTY VERSUS UNCEMENTED TOTAL HIP ARTHROPLASTY FOR DISPLACED FEMORAL NECK FRACTURES IN PATIENTS OVER 60 YEARS: A PROSPECTIVE RANDOMIZED STUDY. THE AIM OF THIS STUDY IS TO COMPARE THE FUNCTIONAL OUTCOMES, SURGICAL PARAMETERS, AND COMPLICATIONS OF CEMENTED BHA VERSUS UNCEMENTED THA IN PATIENTS OVER 60 YEARS WITH DISPLACED FEMORAL NECK FRACTURES. IN THIS PROSPECTIVE RANDOMIZED STUDY, 40 PATIENTS (MEAN AGE, 66.7 YEARS) WITH DISPLACED FEMORAL NECK FRACTURES WERE ALLOCATED TO EITHER UNCEMENTED THA (GROUP 1, N=20) OR CEMENTED BHA (GROUP 2, N=20). FOR UNCEMENTED THA, THE CAPSULE AND EXTERNAL ROTATORS WERE REPAIRED WITH NON-ABSORBABLE SUTURES (ETHIBOND 5), AND THE WOUND WAS CLOSED IN LAYERS OVER A SUCTION DRAIN. ONE SUPERFICIAL INFECTION OCCURRED IN THE THA GROUP (5%) AT 14 DAYS, RESOLVED WITH ORAL ANTIBIOTICS BY ONE MONTH (P=1.0, FISHER'S EXACT TEST). REPORTED COMPLICATIONS INCLUDE: ETHIBOND 5. SUPERFICIAL INFECTION (N=1). TREATMENT: ORAL ANTIBIOTICS. IN CONCLUSION, UNCEMENTED THA OFFERS SUPERIOR EARLY FUNCTIONAL OUTCOMES COMPARED TO CEMENTED BHA FOR DISPLACED FEMORAL NECK FRACTURES IN PATIENTS OVER 60 YEARS, WHILE BHA REDUCES SURGICAL TIME AND BLOOD LOSS. LONG-TERM FUNCTIONAL RESULTS ARE COMPARABLE, SUGGESTING TREATMENT SHOULD BE TAILORED TO PATIENT FACTORS LIKE BONE QUALITY, COMORBIDITIES, AND FUNCTIONAL EXPECTATIONS. FUTURE STUDIES SHOULD EXPLORE LONG-TERM OUTCOMES AND DUAL-MOBILITY CUPS TO REDUCE DISLOCATION RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638170 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention