BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12667077 · Received October 20, 2021

    Report

    Report Number
    2210968-2021-10048
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    January 2, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6. HEALTH EFFECT - CLINICAL CODE. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND OBTAINED. 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: VICRYL SUTURES, DERMABOND, INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? VICRYL SUTURES: INTRAOPERATIVE BLOOD LOSS REQUIRING POSTOPERATIVE TRANSFUSION, HEMATOMA, WOUND LEAKAGE, WOUND DEHISCENCE, TREATMENT: ADEQUATE DEBRIDEMENT AND SUTURING, DELAYED WOUND HEALING. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS: VICRYL SUTURES, DERMABOND, 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? NO ADDITIONAL INFORMATION CAN BE PROVIDED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NOT RECEIVED. 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: VICRYL SUTURES, DERMABOND, INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? VICRYL SUTURES: INTRAOPERATIVE BLOOD LOSS REQUIRING POSTOPERATIVE TRANSFUSION, HEMATOMA, WOUND LEAKAGE, WOUND DEHISCENCE, TREATMENT: ADEQUATE DEBRIDEMENT AND SUTURING, DELAYED WOUND HEALING. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS: VICRYL SUTURES, DERMABOND, 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NOTE: RELATED EVENTS REPORTED ON MW# 2210968-2021-10047, MW# 2210968-2021-10048. CITATION: CITATION: ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2021);141:663¿668. HTTPS://DOI.ORG/10.1007/S00402-020-03674-2.

    Description of Event or Problem · 1

    TITLE: THE USE OF 2-OCTYL CYANOACRYLATE AS AN ADJUVANT TO WOUND CLOSURE IN TOTAL KNEE ARTHROPLASTY. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE WHETHER THE USE OF OCA AS A SUPPLEMENT TO CONVENTIONAL WOUND CLOSURE REDUCES THE INCIDENCE OF WOUND COMPLICATIONS FOLLOWING TKA. A TOTAL OF 1106 PATIENTS WHO UNDERWENT TKA FOR SYMPTOMATIC END-STAGE OSTEOARTHRITIS (OA) BETWEEN 2012 AND 2017 WERE INCLUDED IN THE STUDY. THE FIRST 562 PATIENTS (145 MALE AND 417 FEMALE; MEAN AGE OF 66.7 ± 8.5 YEARS; MEAN BMI OF 25.1 ± 3.5) WHO DID NOT RECEIVE 2-OCTYL CYANOACRYLATE (OCA) WERE GROUPED INTO THE CONTROL GROUP, AND THE SUBSEQUENT 544 PATIENTS (167 MALE AND 377 FEMALE; MEAN AGE OF 66.3 ± 9.2 YEARS; MEAN BMI OF 25.3 ± 3.5) WHO RECEIVED OCA AS AN ADJUVANT TO WOUND CLOSURE WERE GROUPED INTO THE OCA GROUP. THE SAME CLOSURE TECHNIQUE WAS USED FOR ALL CASES. SPECIFICALLY, THE CAPSULE WAS REPAIRED USING ABSORBABLE SUTURE (1-0 VICRYL; ETHICON, INC), THE RETINACULAR LAYER WAS SUTURED WITH A COMPETITOR BIDIRECTIONAL BARBED SUTURE, AND THE SUBCUTANEOUS TISSUES WERE CLOSED WITH ABSORBABLE SUTURE (2-0 VICRYL; ETHICON, INC). FINALLY, THE SKIN WAS APPROXIMATED WITH STAPLES. IN THE OCA GROUP, DERMABOND (ETHICON INC, SOMERVILLE, NJ) WAS USED AS AN ADJUVANT TO STAPLE CLOSURE. ALL PATIENTS WERE FOLLOWED UP FOR AT LEAST 2 YEARS. REPORTED COMPLICATIONS INCLUDE INTRAOPERATIVE BLOOD LOSS REQUIRING POSTOPERATIVE TRANSFUSION (N=65); HEMATOMA (N=37) AND WOUND LEAKAGE (N=64) WERE SUCCESSFULLY CONTROLLED WITH LOCAL WOUND CARE WITHOUT SURGICAL INTERVENTION; WOUND DEHISCENCE (N=39) REQUIRING SURGICAL TREATMENT INCLUDING ADEQUATE DEBRIDEMENT AND SUTURING IN 7 CASES IN THE CONTROL GROUP AND 2 IN THE OCA GROUP AND THE REMAINING WERE HEALED WITH CONSERVATIVE TREATMENT; DELAYED WOUND HEALING (N=33) WHICH WERE HEALED WITHIN 1 MONTH POSTOPERATIVELY WITHOUT ANY ADDITIONAL TREATMENT; AND SUPERFICIAL INFECTION (N=2) THAT RESOLVED WITH ORAL OR INTRAVENOUS ANTIBIOTICS AND LOCAL WOUND CARE WITHOUT AN ADDITIONAL OPERATION. IN CONCLUSION, THE PRESENT STUDY PROVIDES EVIDENCE THAT THE ADDITION OF OCA REDUCES THE INCIDENCE OF WOUND LEAKAGE, WOUND DEHISCENCE, DELAYED WOUND HEALING AND SUPERFICIAL INFECTION AFTER TKA COMPARED TO CONVENTIONAL WOUND CLOSURE AT A 2-YEAR FOLLOW-UP. BASED ON THE OUTCOMES ABOVE, WE DECIDED TO USE OCA ROUTINELY FOR WOUND CLOSURE AFTER TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566396 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention