BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 10825095 · Received November 11, 2020

    Report

    Report Number
    2210968-2020-08971
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    October 23, 2018
    Report Date
    October 26, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 12/09/2020 ADDITIONAL INFORMATION: B3 THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: -DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (SILK SUTURE, VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (FAT LIQUEFACTION, POORLY HEALED INCISION, INCISION DEHISCENCE, SUPERFICIAL INFECTION) DESCRIBED IN THE ARTICLE? -DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (SILK SUTURE, VICRYL SUTURE) USED IN THIS PROCEDURE? -PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE -WERE THE CASES 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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). (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 (SILK SUTURE, VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (FAT LIQUEFACTION, POORLY HEALED INCISION, INCISION DEHISCENCE, SUPERFICIAL INFECTION) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (SILK SUTURE, VICRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: MED SCI MONIT, 2018; 24: 7563-7569; DOI: 10.12659/MSM.910785. NOTE: EVENT REPORTED VIA MW 2210968-2020-08971 FOR EVENTS RELATED TO SILK SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPARISON OF NONABSORBABLE AND ABSORBABLE SUTURE IN TOTAL KNEE ARTHROPLASTY". AUTHOR(S): SHUGUANG LIU, YUNMEI WANG, RONAK N. KOTIAN, HUI LI, YUFEI MI, YUMIN ZHANG, XIJING HE CITATION: MED SCI MONIT, 2018; 24: 7563-7569; DOI: 10.12659/MSM.910785. THIS STUDY AIMED TO DETERMINE WHETHER ABSORBABLE SUTURE IS BETTER THAN NONABSORBABLE SUTURE IN TOTAL KNEE ARTHROPLASTY (TKA). FROM APR2017 TO OCT2017, 180 PATIENTS (N=55 MALE AND N=125 FEMALE; AVERAGE AGE OF 65.18 YEARS±8.41 YEARS [RANGED 47-90 YEARS]) UNDERWENT TOTAL KNEE ARTHROPLASTY WHICH WERE DIVIDED INTO TWO GROUPS FOR WOUND CLOSURE: NONABSORBABLE GROUP (N=80; N=57 FEMALE AND N=23 MALE; AGE OF 65.7 (47¿80) YEARS), AND ABSORBABLE GROUP (N=100; N=69 FEMALE AND N=31 MALE; AGE OF 64.67 (47¿87) YEARS). THE NONABSORBABLE SUTURE WAS ETHICON MERSILK® 2-0/T, THE 2-0 ABSORBABLE WIRE TYPE WAS ETHICON COATED VICRYL 2-0 WITH CT-1 NEEDLE, AND THE 4-0 ABSORBABLE WIRE TYPE WAS ETHICON COATED VICRYL 4-0 WITH FS-2 NEEDLE. POSTOPERATIVE COMPLICATIONS IN NON-ABSORBABLE GROUP INCLUDED FAT LIQUEFACTION AND ASEPTIC EXUDATE (N=6) WHICH BOTH HEALED AFTER CHANGING THE GAUZE SEVERAL TIMES; POORLY HEALED INCISION (N=3) WHICH WERE REMOVED AND 1-2 STITCHES WERE ADDED IN THE HOSPITAL; INCISION DEHISCENCE (N=1) WHICH WAS REMOVED AND TREATED WITH DEBRIDEMENT AND RE-SUTURING; AND SUPERFICIAL INFECTION (N=1) WHICH WAS TREATED WITH DEBRIDEMENT AND INTRAVENOUS ANTIBIOTIC. POSTOPERATIVE COMPLICATIONS IN ABSORBABLE GROUP INCLUDED FAT LIQUEFACTION (N=1) WHICH HEALED AFTER MULTIPLE GAUZE REPLACEMENT. IT IS WORRISOME WHEN THE SKIN EDGE IS SUTURED TOO TIGHTLY, WHICH IN TURN HINDERS DRAINING OF LIQUEFACTION OF SUBCUTANEOUS FAT AND EXUDATES. THIS LEADS TO EXTENSIVE SUBCUTANEOUS NECROSIS AND FURTHER ACCUMULATION OF NECROTIC TISSUE, CAUSING INFECTION. LOWER INCIDENCE OF LIQUEFACTION IN THE ABSORBABLE GROUP THAN IN THE NONABSORBABLE GROUP. SKIN INCISIONS IN THE ABSORBABLE GROUP DRIED UP AFTER CHANGING THE GAUZE ONCE OR TWICE. USE OF ABSORBABLE SUTURE IN TKA CAN REDUCE THE INCIDENCE OF FATTY LIQUEFACTION, REDUCE THE FREQUENCY OF GAUZE CHANGE, REDUCE HOSPITAL LOS, IMPROVE COSMETIC APPEARANCE, AND REDUCE THE OVERALL ECONOMIC EXPENDITURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288258 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention