BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 14567556 · Received June 1, 2022

    Report

    Report Number
    2210968-2022-04196
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    January 1, 2020
    Report Date
    June 14, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-04197. CITATION: CHINESE JOURNAL OF ORTHOPAEDIC SURGERY DOI:10.3977/J.ISSN .1005-8478.2020.18.08

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 6/14/2022. 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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS 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?

    Description of Event or Problem · 0

    TITLE: ENHANCED QUADRUPLED AUTOGENOUS HAMSTRING TENDON GRAFT FOR ANATOMIC SINGLE BUNDLE RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE CLINICAL OUTCOMES OF ENHANCED QUADRUPLED AUTOGENOUS HAMSTRING TENDON GRAFT FOR AN ATOMIC SINGLE-BUNDLE RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT (ACL). FROM JANUARY 2015 TO DECEMBER 2018, 72 PATIENTS UNDERWENT ANATOMIC SINGLE-BUNDLE ACL RECONSTRUCTION FOR ACL TEARS. OF THEM, 34 PATIENTS HAD ACL RECONSTRUCTION PER GRAFT PREPARATION, WHILE THE REMAINING 38 PATIENTS RECEIVED THE GRAFT ENHANCED BY THE UNABSORBABLE SUTURES FOR ACL RECONSTRUCTION. THE KNEE STABILITIES REVEALED BY STRESS TESTS, LYSHOLM SCORES AND MRI GRADES WERE COMPARED BETWEEN THE TWO GROUPS. THE CONVENTIONAL GROUP USE JOHNSON & JOHNSON ETHIBOND 2-0 NON-ABSORBABLE SUTURE ON BOTH ENDS OF TENDON AND IN THE AUGMENTATION GROUP ETHICON 2-0 NON-ABSORBABLE SUTURE WAS USED. REPORTED COMPLICATIONS INCLUDED TWO PATIENTS IN THE EARLY STAGE OF THE CONVENTIONAL GROUP HAD THE FEMORAL SUSPENSORY PLATE POSITION NOT APPOSED TO THE FEMUR, AND REOPERATION WAS PERFORMED TO TIGHTEN THE TRACTION LINE UNDER DIRECT VISION BY INCISION. 3 CASES IN CONVENTIONAL GROUP AND 2 CASES IN ENHANCED GROUP HAD POOR HEALING OF TIBIAL TUNNEL SKIN INCISION, WHICH WERE HEALED AFTER DEBRIDEMENT AND DRESSING CHANGE FOR 3 WEEKS IN CONCLUSION THE ENHANCED QUADRUPLED AUTOGENOUS HAMSTRING TENDON GRAFT DOES FACILITATE TO RELIEVE TENSION IN THE PROCESS OF LIGAMENT HEALING AND AVOID THE LIGAMENT RELAXATION INDUCED BY EARLY REHABILITATION EXERCISES FOR SINGLE-ANATOMIC ACL RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731680 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention