BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22038915 · Received May 16, 2025

    Report

    Report Number
    2210968-2025-05462
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 16, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. 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: REV ESP CIR ORTOP TRAUMATOL. 2025 MAR 27:S1888-4415(25)00059-1. ENGLISH, SPANISH. HTTPS://DOI.ORG/10.1016/J.RECOT.2025.03.006. EPUB AHEAD OF PRINT. PMID: 40157721.

    Description of Event or Problem · 0

    TITLE: CLINICAL OUTCOMES OF CLOSURING TECHNIQUE IN TOTAL HIP ARTHROPLASTY AND TOTAL KNEE ARTHROPLASTY: A COMPARATIVE STUDY OF STAPLES TECHNIQUE VS TRICLOSAN-COATED BARBED SUTURES. THE PRESENT STUDY AIMED TO ANALYZE THE RESULTS OF COMPARISON STAPLE CLOSURE TECHNIQUE IN THA AND TKA TO CONTINUOUS SUBCUTICULAR TRICLOSAN-COATED BARBED ABSORBABLE SUTURE IN ADDITION TO TYPE AND RATE OF WOUND COMPLICATION. BETWEEN (B)(6) 2014 TO (B)(6) 2024, A TOTAL OF 3147 PATIENTS WHO UNDERWENT ARTHROPLASTY WITH HIP OSTEOARTHRITIS AGED 29-92 YEARS WITH PRIMARY OR SECONDARY KNEE AND HIP OSTEOARTHRITIS UNDERGOING THA/TKA IN OUR DEPARTMENT. PATIENTS WERE DIVIDED INTO TWO GROUPS BY CLOSURE METHOD: GROUP 1 (WITH STAPLES), GROUP 2 (WITH BARBED SUTURES), GROUP 1 HAS 853 FEMALE AND 34 MALES WHILE GROUP 2 HAS 941 FEMALE AND 682 MALES. THE CLOSURE TECHNIQUES IN THIS STUDY UTILIZED DIFFERENT SUTURE MATERIALS AND METHODS FOR THE DEEP AND SUPERFICIAL LAYERS. IN GROUP 1, FASCIA AND SUBCUTANEOUS LAYERS WERE APPROXIMATED USING INTERRUPTED SUTURES WITH VICRYL 2-0, WHILE SKIN CLOSURE WAS ACHIEVED WITH A COVIDIEN® SKIN STAPLER. IN GROUP 2, A CONTINUOUS BARBED SUTURING TECHNIQUE WITH STRATAFIX WAS EMPLOYED FOR BOTH THE FASCIA/SUBCUTANEOUS LAYERS AND SKIN. BOTH GROUPS RECEIVED STANDARDIZED PREOPERATIVE CARE, INCLUDING ANTIBIOTIC PROPHYLAXIS, ANTICOAGULATION, AND ANESTHESIA PROTOCOLS. ADDITIONALLY, ALL PATIENTS RECEIVED 3 GRAMS OF INTRAVENOUS TRANEXAMIC ACID PREOPERATIVELY. TOTAL KNEE ARTHROPLASTY WAS PERFORMED USING A MEDIAL PARAPATELLAR APPROACH, WHILE TOTAL HIP ARTHROPLASTY UTILIZED A POSTERIOR APPROACH WITH A MUSCLE-SPARING TECHNIQUE, PRESERVING THE PIRIFORMIS, ILIOTIBIAL BAND, AND QUADRATUS FEMORIS WITHOUT CAPSULAR CLOSURE. POSTOPERATIVELY, AN AQUACEL AG DRESSING WAS APPLIED AND REMAINED IN PLACE FOR 14 DAYS. REPORTED COMPLICATIONS ARE THE FOLLOWING: VICRYL 2-0 SUTURES (ETHICON) -MODERATE BLEEDING (N= 29) TREATMENT: AQUACEL AG SURGICAL DRESSINGS WERE OCCASIONALLY CHANGED WITHIN 1-4 DAYS POST-SURGERY -WOUND DEHISCENCE (N= 11) TREATMENT: NOT REPORTED - EARLY FALLS WITH SUTURE BREAKAGE AFTER OPERATION (N=4) TREATMENT: NOT REPORTED - STITCH ABSCESS (N=6) TREATMENT: MANAGED OUTPATIENT WITH CLEANING, ANTIBIOTIC OINTMENT, AND DRESSING CHANGES EVERY TWO DAYS - UNKNOWN EVENT (N=50) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD READMISSION WITH UNKNOWN CAUSE. STRATAFIX SUTURE (ETHICON) -MODERATE BLEEDING (N=28) TREATMENT: AQUACEL AG SURGICAL DRESSINGS WERE OCCASIONALLY CHANGED WITHIN 1-4 DAYS POST-SURGERY -WOUND DEHISCENCE (N=11) TREATMENT: NOT REPORTED - EARLY FALLS WITH SUTURE BREAKAGE AFTER OPERATION (N=3) TREATMENT: NOT REPORTED - STITCH ABSCESS (N=5) TREATMENT: MANAGED OUTPATIENT WITH CLEANING, ANTIBIOTIC OINTMENT, AND DRESSING CHANGES EVERY TWO DAYS - UNKNOWN EVENT (N=46). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD READMISSION WITH UNKNOWN CAUSE IN CONCLUSION, THE STUDY DEMONSTRATED THAT THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THE FREQUENCY OF WOUND COMPLICATIONS BETWEEN THE TWO WOUND CLOSURE METHODS IN THA AND TKA SURGERIES, INDICATING COMPARABLE SURGICAL OUTCOMES IN TERMS OF WOUND HEALING AND COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164864 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other