BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12584966 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09270
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    April 26, 2021
    Report Date
    October 6, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED: DERMABOND PRINEO, VICRYL SUTURE, CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS OF: NECROSIS, DEHISCENCE, SUPERFICIAL INFECTION, SCAR DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS: DERMABOND PRINEO, VICRYL SUTURE, USED IN THIS PROCEDURE? 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. CITATION: THE JOURNAL OF ARTHROPLASTY (2021); 36:3141-3147. HTTPS://DOI.ORG/10.1016/J.ARTH.2021.04.033. NOTE: EVENTS REPORTED ON MW#: 2210968-2021-09269.

    Description of Event or Problem · 1

    TITLE: 2-OCTYL CYANOACRYLATE TOPICAL ADHESIVE AS AN ALTERNATIVE TO SUBCUTICULAR SUTURE FOR SKIN CLOSURE AFTER TOTAL KNEE ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL IN THE SAME PATIENT. AUTHORS: KEUN YOUNG CHOI, MD, IN JUN KOH, MD, PHD, MAN SOO KIM, MD, PHD, DONG CHUL PARK, MD, YONG GYU SUNG, MD, YONG IN, MD, PHD. CITATION: THE JOURNAL OF ARTHROPLASTY (2021); 36:3141-3147. HTTPS://DOI.ORG/10.1016/J.ARTH.2021.04.033. THE PURPOSE OF THIS PROSPECTIVE, DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY WAS TO COMPARE THE EFFICACY AND SAFETY BETWEEN DERMABOND PRINEO AND SUBCUTICULAR SUTURE FOR SKIN CLOSURE IN PATIENTS UNDERGOING SAME-DAY BILATERAL TOTAL KNEE ARTHROPLASTIES (TKAS). A TOTAL OF 50 PATIENTS (ASIAN; 5 MALE AND 45 FEMALE; MEAN AGE OF 69.3 YEARS; MEAN BMI OF 27.0) WITH OSTEOARTHRITIS ON BOTH KNEES WHO UNDERWENT SAME-DAY BILATERAL TKAS FROM MARCH 2019 TO DECEMBER 2019 WERE INCLUDED IN THE STUDY. IN EACH PATIENT, ONE KNEE WAS RANDOMLY ASSIGNED TO THE DERMABOND PRINEO GROUP (N = 50) AND THE OTHER KNEE WAS ASSIGNED TO THE SUBCUTICULAR SUTURE GROUP (N = 50). CLOSURE OF CAPSULE WAS PERFORMED WITH CONTINUOUS SUTURE USING 1-0 VICRYL (ETHICON) SUTURE MATERIAL. SUBCUTANEOUS INTERRUPTED SUTURE WAS PERFORMED WITH 1-0 AND 2-0 VICRYL. FINALLY, FOR THE KNEE ALLOCATED TO THE DERMABOND PRINEO GROUP, SKIN CLOSURE WAS PERFORMED WITH 2-OCTYL CYANOACRYLATE TOPICAL ADHESIVE (DERMABOND) WITH A SELF-ADHESIVE MESH (PRINEO); PRINEO WAS CUT FOR ADEQUATE LENGTH COVERING MORE THAN 1 CM OF SKIN INCISION MARGIN. DERMABOND WAS APPLIED ON PRINEO IN LIQUID FORM. AFTER WAITING ABOUT 60 SECONDS FOR POLYMERIZATION, STERI-STRIP WAS APPLIED TO COVER THE PRINEO FOR MASKING. FOR THE OTHER KNEE ALLOCATED TO THE SUBCUTICULAR SUTURE GROUP, SKIN CLOSURE WAS PERFORMED WITH RUNNING SUBCUTICULAR SUTURE WITH 3-0 NYLON. AFTER, STERI-STRIP WAS ALSO APPLIED FOR MASKING. REPORTED COMPLICATIONS INCLUDED NECROSIS (N=?); DEHISCENCE (N=?); SUPERFICIAL INFECTION (N=?); VANCOUVER SCAR SCALE TOTAL SCORE OF 6.3 AND 6.5 (N=?), PATIENT SCAR ASSESSMENT SCALE WITH A MEAN TOTAL SCORE OF 26.0 AND 27.0 (N=?), AND OBSERVER SCAR ASSESSMENT SCALE WITH A MEAN TOTAL OF 25.7 AND 25.2 (N=?) IN DERMA PRINEO GROUP AND SUBCUTICULAR GROUP, RESPECTIVELY; HOLLANDER WOUND EVALUATION SCALE SUBOPTIMAL WOUND (N=?); COSMESIS VISUAL ANALOG SCALE OF 3.8 (N=?). IN CONCLUSION, DERMABOND PRINEO PROVIDED QUICKER WOUND CLOSURE, SHORTER STITCH OUT TIME, AND BETTER WOUND MARGIN COAPTATION DURING THE EARLY POSTOPERATIVE PERIOD BUT SIMILAR EFFICACY AND SAFETY TO SUBCUTICULAR SUTURE. THUS, BASED ON THESE RESULTS, DERMABOND PRINEO COULD SERVE AS A USEFUL ALTERNATIVE TO SKIN SUTURING AFTER TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482671 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention