BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8790341 · Received July 15, 2019

    Report

    Report Number
    2210968-2019-84284
    Event Type
    Injury
    Date Received
    July 15, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CITATION: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY. 2010; 26(5): PP 630-6 DOI: 10.1016/J.ARTHRO.2009.09.006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: OUTCOME OF ARTHROSCOPIC SINGLE-BUNDLE VERSUS DOUBLE-BUNDLE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT: A PRELIMINARY 2-YEAR PROSPECTIVE STUDY" AUTHORS: SE-JIN PARK, M.D.; YOUNG-BOK JUNG, M.D.; HWA-JAE JUNG, M.D.; HO-JOONG JUNG, M.D.; HUN KYU SHIN, M.D.; EUGENE KIM, M.D.; KWANG-SUP SONG, M.D.; GWANG-SIN KIM, M.D.; HYE-YOUNG CHEON, P.A.; SEONWOO KIM, PH.D. CITATION: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY. 2010; 26(5): PP 630-6 DOI: 10.1016/J.ARTHRO.2009.09.006. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE CLINICAL RESULTS OF ARTHROSCOPIC SINGLE-BUNDLE AND DOUBLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION. THE AUTHORS DESIGNED A PROSPECTIVE STUDY THAT INCLUDED 113 PATIENTS WITH AN ISOLATED ACL INJURY FROM APRIL 2004 TO FEBRUARY 2007. OF THE 113 PATIENTS, 50 PATIENTS COMPRISED THE SINGLE-BUNDLE RECONSTRUCTION GROUP (GROUP S; 34 MALE AND 16 FEMALE PATIENTS; AGE RANGE: 16 TO 54 YEARS OLD) AND 63 PATIENTS COMPRISED THE DOUBLE-BUNDLE RECONSTRUCTION GROUP (GROUP D; 48 MALE AND 15 FEMALE PATIENTS; AGE RANGE: 17 TO 57 YEARS OLD). DURING THE SURGICAL PROCEDURE IN GROUP D, ETHIBOND 5-0 (ETHICON) WAS USED AT THE END OF EACH TENDON FOR SUTURING OF EACH GRAFT WAS CONNECTED TO THE MEASURING DEVICE TO DETERMINE THE TENSION LEVEL; THE MEASURING DEVICE WAS PULLED WITH A 10- TO 15-LB FORCE AS THE KNEE JOINT UNDERWENT CYCLIC LOADING AT 0° TO 90° FOR 20 CYCLES. IN GROUP D, REPORTED COMPLICATIONS INCLUDED SUPERFICIAL OR INTRA-ARTICULAR BACTERIAL INFECTIONS (N-2) WHICH WERE TREATED WITH ARTHROSCOPIC DEBRIDEMENT AND IRRIGATION AND HEALED WITHOUT FURTHER COMPLICATIONS AND INFECTION (N-1) WHICH REQUIRED ARTHROSCOPIC DEBRIDEMENT AND IRRIGATION 3 TIMES AND HAD REVISION ACL SURGERY AT ANOTHER HOSPITAL 2 YEARS AFTER THE INDEX OPERATION. THE AUTHORS FOUND THAT DOUBLE-BUNDLE RECONSTRUCTION OF THE ACL USING 2 TIBIAL TUNNELS AND 2 FEMORAL TUNNELS SHOWED NO DIFFERENCES IN STABILITY RESULTS OR ANY OTHER CLINICAL ASPECTS OR IN TERMS OF PATIENT SATISFACTION. SO THE STUDY DOES NOT SUPPORT THE HYPOTHESIS THAT DOUBLE-BUNDLE ACL RECONSTRUCTION WOULD BE ADVANTAGEOUS IN RESTORING ANTERIOR AND ROTATIONAL STABILITY, AS WELL AS PROVIDING BETTER OBJECTIVE CLINICAL RESULTS, COMPARED WITH SINGLE-BUNDLE RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581521 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention