BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19068055 · Received April 8, 2024

    Report

    Report Number
    2210968-2024-04044
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    August 1, 2021
    Report Date
    April 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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 ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL & MONOCRYL SUTURES) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: WOUND COMPLICATIONS INCLUDING STITCH ABSCESS, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL & MONOCRYL SUTURES) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL & MONOCRYL SUTURES) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: ORTHOPEDICS. 2021;44(4):216-222 DOI: 10.3928/01477447-20210621-06. JOURNAL ARTICLE ATTACHED. NOTE: EVENTS REPORTED ON MW# 2210968-2024-04043, MW# 2210968-2024-04044, MW# 2210968-2024-04045, MW# 2210968-2024-04046. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE: A PROSPECTIVE, RANDOMIZED EVALUATION OF THE QUALITY OF WOUND CLOSURE WITH BARBED VERSUS STANDARD SUTURE AFTER TOTAL JOINT ARTHROPLASTY. THE PURPOSE OF THE STUDY WAS TO COMPARE THE QUALITY OF RUNNING KNOTLESS BARBED SUTURE VS STANDARD MONOFILAMENT SUTURE WOUND CLOSURE WITH RESPECT TO WOUND DRAINAGE AND HEALING COMPLICATIONS AFTER TOTAL JOINT ARTHROPLASTY. BETWEEN 2016 AND 2018, A TOTAL OF 1,000 PATIENTS ( 446 MALE AND 554 FEMALE) WITH A MEAN AGE OF 68.7 YEARS WERE INCLUDED IN THE STUDY. THESE CONSECUTIVE PRIMARY JOINT ARTHROPLASTY PATIENTS HAD SOFT TISSUE AND SKIN CLOSURE WITH KNOTLESS BARBED SUTURE (KBS) OR STANDARD MONOFILAMENT SUTURE, WHICH SUBSEQUENTLY DIVIDING THE PATIENTS INTO TWO GROUPS; THE BARBED SUTURE GROUP CONSISTING OF 476 PATIENTS (USING 2-0 VICRYL SUTURE FOR APPROXIMATING THE DEEP-INTERMEDIATE LAYER), AND THE STANDARD MONOFILAMENT GROUP WITH 463 PATIENTS (USING 1 VICRYL POP-OFF SUTURES FOR THE RETINACULUM, A 2-0 VICRYL SUTURES TO APPROXIMATE THE DEEP¿INTERMEDIATE LAYER, A 2-0 MONOCRYL SUTURE FOR A RUNNING SUBCUTANEOUS CLOSURE, AND A 3-0 MONOCRYL SUTURE FOR A RUNNING SUBCUTICULAR CLOSURE). ALL INCISIONS WERE EVALUATED AT 2 WEEKS, 6 WEEKS, 12 WEEKS, AND 1 YEAR POSTOPERATIVELY. REPORTED COMPLICATIONS INCLUDE: (N=6) PREMATURE DISENGAGEMENT OF STANDARD SUTURE FROM THE NEEDLE, AND (N=5) WOUND COMPLICATIONS INCLUDING STITCH ABSCESS OR WOUND IRRITATION FOR BARBED SUTURE GROUP; AND, (N=13) PREMATURE DISENGAGEMENT OF STANDARD SUTURE FROM THE NEEDLE, AND (N=16) WOUND COMPLICATIONS INCLUDING STITCH ABSCESS OR WOUND IRRITATION FOR THE STANDARD MONOFILAMENT SUTURE GROUP. CONCLUSION: POSTOPERATIVE WOUND DRAINAGE IS A PROXY FOR SUPERFICIAL AND DEEP INFECTION AFTER JOINT ARTHROPLASTY. IN ADDITION TO BEING FASTER AND LESS EXPENSIVE OVERALL, THE MOST MEANINGFUL CLINICAL IMPACT OF BARBED SUTURES MAY BE THEIR ABILITY TO PROVIDE WATERTIGHT CLOSURES. CONTINUED PROSPECTIVE EVALUATION OF WOUND CLOSURE WITH KBS THROUGH DRESSING WEIGHT AND SIZE OF DRESSING AREA IN ORTHOPEDIC SETTINGS IS WARRANTED. FUTURE META-ANALYSES OF RANDOMIZED TRIALS SUCH AS THIS STUDY WILL HELP TO FURTHER DELINEATE THE POTENTIAL ADVANTAGES OF BARBED SUTURE OVER STANDARD SUTURE IN ORTHOPEDICS. THIS STUDY DOES REPRESENT A RELATIVELY LARGE GROUP OF PATIENTS, AND THE COMPARISONS INDICATE POSSIBLE BENEFITS OF BARBED SUTURE IN JOINT ARTHROPLASTY WOUND CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288390 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other