BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9980836 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03251
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS CITATION: MED SCI MONIT, 2018; 24: 8401-8407; DOI: 10.12659/MSM.912854. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A MODIFIED STRATEGY USING BARBED SUTURES FOR WOUND CLOSURE IN TOTAL JOINT ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, SELF-CONTROLLED CLINICAL TRIAL". AUTHOR: RUI LI, MING NI, JING ZHAO, XIANG LI, ZHUO ZHANG, PENG REN, CHI XU, JI-YING CHEN, CITATION: MED SCI MONIT, 2018; 24: 8401-8407; DOI: 10.12659/MSM.912854. THIS PROSPECTIVE, RANDOMIZED, SELF-CONTROLLED TRIAL AIMED TO FURTHER DETERMINE THE EFFICIENCY AND SAFETY AND TO INTRODUCE THE MODIFIED SUTURING METHOD USING BARBED SUTURE IN TOTAL JOINT ARTHROPLASTY (TJA). FROM AUGUST 2015 TO DECEMBER 2016, A TOTAL OF 84 PATIENTS WHO HAD UNDERGONE PRIMARY SIMULTANEOUS BILATERAL TOTAL KNEE ARTHROPLASTY (TKA) OR TOTAL HIP ARTHROPLASTY (THA) WERE ENROLLED IN THIS STUDY. THERE WERE 46 PATIENTS (N=32 MALES AND N=14 FEMALES, MEAN AGE: 43.76 YEARS, AGE RANGE: 22 TO 70 YEARS, BMI: 23.78KG/M2) IN THE THA GROUP. ON THE OTHER HAND, THERE WERE 38 PATIENTS (N=8 MALES AND 30 FEMALES, MEAN AGE: 60.11 YEARS, AGE RANGE: 37 TO 70 YEARS, BMI: 26.76KG/M2) IN THE TKA GROUP. THERE WERE 2 SUTURING METHOD CATEGORIES. FOR EACH PATIENT, ONE SIDE WAS RANDOMIZED TO THE BARBED GROUP, THE OTHER SIDE WAS CORRESPONDINGLY DIVIDED INTO THE CONTROL GROUP USING VICRYL (ETHICON). FOR THE BARBED GROUP, RUNNING KNOTLESS #2 QUILL WAS USED FOR THE FASCIA (HIP)/JOINT CAPSULAR (KNEE). AFTER FINISHING THIS LAYER, THE SUTURE WAS NOT CUT; ON THE CONTRARY, A ¿U TURN¿ WAS MADE, SUTURING BACK TOWARDS THE MIDDLE OF THE DEEP FAT LAYER. AFTER REACHING THE MIDDLE OF THE DEEP FAT LAYER, THE SUTURE WAS CUT AND THEN USED #2-0 VICRYL (ETHICON) FOR 2 OR 3 INTERRUPTED SUTURES. IF THE LENGTH OF THE #2 QUILL WAS INSUFFICIENT, MORE INTERRUPTED #2-0 VICRYL WAS USED TO FILL UP THE BLANK. INTERRUPTED SUTURING (#2-0 VICRYL) WAS PERFORMED IN THE SUBCUTANEOUS LAYER, AND THIS LAYER WAS SUTURED TO COMBINE WITH THE SUPERFICIAL FAT LAYER (APPROXIMATELY 0.5 CM). FINALLY, SKIN STAPLES WERE USED. FOR THE CONTROL GROUP, TRADITIONAL METHOD WAS USED, #1 VICRYL (ETHICON) FOR SUCCESSIVE CHAIN-SHAPED SUTURING IN THE FASCIA (HIP)/JOINT CAPSULAR(KNEE) AND #2-0 VICRYL (ETHICON) FOR INVERTED INTERRUPTED SUTURING IN THE FAT AND SUBCUTANEOUS LAYERS. THEN, STAPLES WERE USED FOR THE SKIN. COMPLAINT IN THA PATIENTS INCLUDED CONTINUOUS EXUDATION (N=1 IN BARBED GROUP, N=1 IN CONTROL GROUP). FOR TKA, REPORTED COMPLICATIONS ARE SWELLING (N=1 IN BARBED GROUP, N=1 IN CONTROL GROUP), CONTINUOUS EXUDATION (N=1 IN BARBED GROUP, N=1 IN CONTROL GROUP), AND STITCH ABSCESS (N=1 IN CONTROL GROUP). ALL PATIENTS WITH MINOR COMPLICATIONS IMPROVED AFTER CONTINUOUS DRESSING CHANGES AND NONE REQUIRED FURTHER SURGICAL INTERVENTION OR EXCESSIVE ANTIBIOTIC USAGE. IN CONCLUSION, BARBED SUTURING WAS A FAST AND SAFE METHOD FOR WOUND CLOSURE IN TJA. THE MODIFIED SUTURING STRATEGY WAS ALSO RECOMMENDED, ESPECIALLY IN COUNTRIES WHERE OPERATION COST WAS NOT ASSOCIATED WITH OPERATION TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445076 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention