BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ VIO 36IN 0 S/A CT

    MDR report key: 10825939 · Received November 11, 2020

    Report

    Report Number
    2210968-2020-08974
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    July 27, 2020
    Report Date
    October 26, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052710
    PMA / PMN Number
    K132580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT TO THE FDA: 12/4/2020 THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: -DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL PLUS SUTURE VCP358 AND STRATAFIX SUTURE SXPP1A401) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (SUPERFICIAL INFECTION 3 MONTHS POST-OP) DESCRIBED IN THE ARTICLE? -DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL PLUS SUTURE VCP358 AND STRATAFIX SUTURE SXPP1A401) USED IN THIS PROCEDURE? -PATIENT DEMOGRAPHICS FOR THE PATIENT THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE -WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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). 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. 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 ETHICON PRODUCT (VICRYL PLUS SUTURE VCP358 AND STRATAFIX SUTURE SXPP1A401) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (SUPERFICIAL INFECTION 3 MONTHS POST-OP) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL PLUS SUTURE VCP358 AND STRATAFIX SUTURE SXPP1A401) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS FOR THE PATIENT THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: CHEN L, YANG J, XIE J, HU Y, ZENG M. CLINICAL OUTCOME OF DIFFERENT SKIN CLOSURE IN TOTAL-KNEE ARTHROPLASTY: RUNNING SUBCUTICULAR CLOSURE VS INTERMITTENT CLOSURE: A RETROSPECTIVE STUDY. MEDICINE 2020;99:34(E21947). HTTP://DX.DOI.ORG/10.1097/MD.0000000000021947. NOTE: EVENTS REPORTED VIA 2210968-2020-08975.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CLINICAL OUTCOME OF DIFFERENT SKIN CLOSURE IN TOTAL-KNEE ARTHROPLASTY: RUNNING SUBCUTICULAR CLOSURE VS INTERMITTENT CLOSURE" AUTHORS: LIANG CHEN, MD , JUNXIAO YANG, MD, JIE XIE, MD, YIHE HU, MD, AND MIN ZENG, MD CITATION: CHEN L, YANG J, XIE J, HU Y, ZENG M. CLINICAL OUTCOME OF DIFFERENT SKIN CLOSURE IN TOTAL-KNEE ARTHROPLASTY: RUNNING SUBCUTICULAR CLOSURE VS INTERMITTENT CLOSURE: A RETROSPECTIVE STUDY. MEDICINE 2020;99:34 (E21947). HTTP://DX.DOI.ORG/10.1097/MD.0000000000021947. THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE CLINICAL OUTCOMES AND RISK OF SURGICAL-SITE INFECTION OF SUBCUTICULAR AND INTERMITTENT CLOSURE AFTER TOTAL-KNEE ARTHROPLASTY (TKA). BETWEEN JAN 2017 AND JUN 2019, 106 PATIENTS UNDERWENT TKA. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: 43 PATIENTS (N=12 MALE, N=31 FEMALE, AGE OF 66.0±8.5, AND BMI OF 25±3.7) HAD RECEIVED RUNNING SUBCUTICULAR CLOSURE (GROUP A) AND 58 PATIENTS (N=13 MALE, N=45 FEMALE, AGE OF 66.9±7.9, AND BMI OF 25.4±4.9) UNDERWENT INTERMITTENT CLOSURE (GROUP B). THE FINAL ANALYSIS WAS CONDUCTED ON 101 PATIENTS SINCE 5 WERE LOST DURING THE 6-MONTH FOLLOW-UP. ABSORBABLE SUTURE WAS USED FOR RUNNING SUBCUTICULAR CLOSURE IN ALL SURGERIES UNTIL APRIL 2018 (GROUP A), WHEREAS INTERMITTENT CLOSURE WAS PERFORMED USING SILK SUTURE (GROUP B). DURING THE PROCEDURE, THE TENDON, SUBCUTANEOUS, AND SKIN LAYERS WERE SEQUENTIALLY CLOSED WITH 0 ABSORBABLE LINE VICRYL PLUS (ETHICON) AND STRATAFIX (ETHICON), A 2-0 POLYDIOXANONE (PDO) (QUILL), AND 3-0 MONODERM (GROUP A) OR SILK (MERSILK; GROUP B) SUTURE, RESPECTIVELY. ONE CASE IN THE RUNNING SUBCUTICULAR CLOSURE GROUP SHOWED SUPERFICIAL INFECTION 3 MONTHS AFTER THE OPERATION. THE PATIENT WAS TREATED WITH SENSITIVE ANTIBIOTICS, DEBRIDEMENT, AND POLYETHYLENE LINER REPLACEMENT. RUNNING SUBCUTICULAR CLOSURE AFTER TKA RESULTS IN A BETTER APPEARANCE COMPARED TO INTERMITTENT CLOSURE, ALTHOUGH NEITHER METHOD HAS AN ADVANTAGE IN TERMS OF FUNCTION AND RISK OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288960 VCL+ VIO 36IN 0 S/A CT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP358H 10705031052710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention