BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18619412 · Received January 31, 2024

    Report

    Report Number
    2210968-2024-00853
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    June 12, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4), ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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 ANY OF THE ETHICON PRODUCTS INVOLVED (DERMABOND UNK, VICRYL SUTURE UNK) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE (NECROSIS, DRAINAGE TREATMENT)? WHICH SPECIFIC ETHICON PRODUCTS (DERMABOND UNK, VICRYL SUTURE UNK) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (DERMABOND UNK, VICRYL SUTURE UNK) 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. CITATION: J. CLIN. MED. 2023, 12, 3985. HTTPS://DOI.ORG/10.3390/JCM12123985 RELATED EVENTS CAPTURED VIA: MW# 2210968-2024-00852 , MW# 2210968-2024-00853. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: WATER-TIGHT ARTHROTOMY JOINT CLOSURE OF MODIFIED INTERVASTUS APPROACH IN TOTAL KNEE ARTHROPLASTY THE AIM OF THE STUDY IS TO DESCRIBE THE DETAILS OF THE TECHNICAL STEPS INVOLVED IN PERFORMING THE WATER-TIGHT ARTHROTOMY JOINT CLOSURE TECHNIQUE THAT WE DEVELOPED AND USE. A TOTAL OF 536 PATIENTS (AVERAGE AGE: 62 YEARS, AVERAGE BODY MASS INDEX: 34 KG/M2) WITH PRIMARY OSTEOARTHRITIS OF THE KNEE UNDERWENT TKA USING THE MODIFIED INTERVASTUS (MIV) APPROACH BETWEEN JANUARY 2019 AND DECEMBER 2021. ARTHROTOMY CLOSURE WAS ACCOMPLISHED USING TWO NUMBER ONE ARTHROTOMY CLOSURE WAS ACCOMPLISHED USING VICRYL (ETHICON) SUTURES AND DERMABOND (ETHICON). THE SUTURE WAS PASSED AT THE CAUDAL END OF THE ARTHROTOMY INCISION AND WAS TIED USING TWO OR THREE KNOTS. THE ONE-INCH-LONG TAIL LEFT AFTER THE SUTURE WAS TIED WAS NOT CUT SHORT (FIGURE 2) AND WAS LATER USED. THE REPORTED COMPLICATION INCLUDED (N=1) DRAINAGE TREATMENT: REOPERATION AND (N=2) SUPERFICIAL SKIN NECROSIS TREATMENT: ANTIBIOTIC. IN CONCLUSION, WE CONCLUDE THAT THE WATER-TIGHT CLOSURE APPROACH CAN ACHIEVE VERY DURABLE, WATER-TIGHT CAPSULE REPAIRS AND RESULTS IN A DECREASE IN POSTOPERATIVE WOUND DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374324 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention