BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 21785616 · Received April 7, 2025

    Report

    Report Number
    2210968-2025-03645
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    January 20, 2025
    Report Date
    April 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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: BMC MUSCULOSKELET DISORD. 2025 JAN 20;26(1):70. HTTPS://DOI.ORG/10.1186/S12891-024-08263-7. PMID: 39828687; PMCID: PMC11744891.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF SURGICAL WOUND INFECTION AND DEHISCENCE FOLLOWING THE USE OF TWO METHODS OF NYLON SUTURES AND SKIN STAPLES IN STAPLES IN DIABETIC MELLITUS PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY SURGERY: A RANDOMIZED CLINICAL TRIAL STUDY. THE AIM OF THIS STUDY IS TO INVESTIGATE THE RATE OF INFECTION AND POST-CLOSURE DEHISCENCE IN WOUNDS CLOSED WITH EITHER NYLON SUTURES OR SKIN STAPLES IN DIABETIC PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY (TKA). BETWEEN FEBRUARY 2024 AND JULY 2024, THIS IS A SINGLE-BLIND RANDOMIZED CLINICAL TRIAL INCLUDING 70 DIABETIC MELLITUS PATIENTS UNDERGOING TKA. THE AVERAGE AGE OF THE PARTICIPANTS WAS 69.17 ± 5.87 YEARS, AND MOST OF THEM WERE WOMEN (67.1%). NO SIGNIFICANT DIFFERENCES WERE OBSERVED BETWEEN THE TWO GROUPS IN TERMS OF DEMOGRAPHIC (AGE, GENDER, SMOKING) AND BASELINE CLINICAL DATA (SEE TABLE 1). PATIENTS WERE SELECTED USING A RESTRICTED RANDOM SAMPLING METHOD AND HAPHAZARDLY ASSIGNED TO STUDY GROUPS USING THE PERMUTED BLOCK RANDOMIZATION TECHNIQUE, INCLUDING THE SUTURE-CLOSED (N = 35) AND STAPLE-CLOSED (N = 35) GROUPS. THE SUBVASTUS APPROACH WAS EMPLOYED USING A PRESS FIT CONDYLAR (PFC) SIGMA DEPUY PROSTHESIS (JOHNSON & JOHNSON, RAYNHAM, MA, USA), IN WHICH TISSUE-SPARING IS SUBSTANTIAL IN RELATION TO THE TRADITIONAL SURGICAL APPROACH FOR KNEE REPLACEMENT. AFTER PLACING THE KNEE PROSTHESIS, THE JOINT CAPSULE WAS CLOSED USING VICRYL SUTURE 2 (POLYGLACTIN 910) AND A SIMPLE CONTINUOUS METHOD. IN ORDER TO CLOSE THE SUBCUTANEOUS LAYER, VICRYL (PGA) 2 - 0 WAS UTILIZED ALONG WITH BURIED NODES. HEMOVAC DRAIN WAS APPLIED FOR ALL PATIENTS AT THE END OF THE SURGERY. THE DRAIN WAS REMOVED ON THE SECOND DAY AFTER THE OPERATION. IN THE SUTURE GROUP, WOUND CLOSURE WAS PERFORMED USING NYLON 2 - 0 (SUPA CO., IRAN) FOLLOWING THE SIMPLE CONTINUOUS METHOD. IN THE STAPLE GROUP, SURGICAL WOUND CLOSURE WAS PERFORMED USING COVIDIN SKIN STAPLERS (APPOSE ULC 35 W). REPORTED COMPLICATIONS ARE WOUND INFECTION RATE (N=?) AND WOUND DEHISCENCE RATE (N=?). IN CONCLUSION, THE USE OF THE STAPLE TECHNIQUE COMPARED TO SUTURE HAD NO DIFFERENCE IN THE RATE OF WOUND OPENING AND INFECTION, BUT FROM A CLINICAL POINT OF VIEW, THE PREVALENCE OF WOUND OPENING AFTER TKA IN PATIENTS WITH THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731863 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other