BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7764271 · Received August 8, 2018

    Report

    Report Number
    2210968-2018-75016
    Event Type
    Injury
    Date Received
    August 8, 2018
    Report Date
    August 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: CLIN ORTHOP RELAT RES (2012) 470:125¿129; DOI 10.1007/S11999-011-2104-7 . (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : PERIOPERATIVE CLOSURE-RELATED COMPLICATION RATES AND COST ANALYSIS OF BARBED SUTURE FOR CLOSURE IN TKA" AUTHOR: JEREMY M. GILILLAND MD, LUCAS A. ANDERSON MD, GRANT SUN BS, JILL A. ERICKSON PA-C, CHRISTOPHER L. PETERS MD. CITATION: CLIN ORTHOP RELAT RES (2012) 470:125¿129; DOI 10.1007/S11999-011-2104-7. THIS RETROSPECTIVE STUDY AIMED TO COMPARE A BARBED SUTURE WITH AN INTERRUPTED SUTURE TECHNIQUE IN LAYERED CLOSURE IN PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) TO DETERMINE IF THE BARBED SUTURE WOULD BE ASSOCIATED WITH (1) SHORTER ESTIMATED CLOSURE TIMES; (2) LOWER COST; AND (3) SIMILAR CLOSURE-RELATED PERIOPERATIVE COMPLICATION RATES. THE BARBED CLOSURE GROUP CONSISTED OF 104 TKA PERFORMED IN 98 PATIENTS (N=32 MALE AND N=66 FEMALE; MEAN AGE SD OF 61 YEARS [11YEARS]) BETWEEN 01JAN2010 AND 15JUL2010. THE STANDARD GROUP CONSISTED OF 87 TKA PERFORMED IN 85 PATIENTS BETWEEN 01JAN2009 AND 15JUL2009. IN THE STANDARD SUTURE CLOSURE, #1 ETHIBOND SUTURES WERE USED IN ARTHROTOMY CLOSURE AND 2-0 MONOCYL SUTURES WERE USED IN SUBDERMAL CLOSURE. SKIN CLOSURE WAS DONE WITH STAPLES. POSTOPERATIVELY COMPLICATIONS INCLUDED HEMATOMA (N=3) TREATED CONSERVATIVELY (N=1) AND WITH IRRIGATION AND DEBRIDEMENT (N=2), CELLULITIS (N=4) TREATED WITH ORAL ANTIBIOTICS AND ARTHROFIBROSIS (N=3) TREATED WITH MANIPULATION UNDER ANESTHESIA. THERE WAS NO DIFFERENCE IN EITHER THE RATE OR TYPE OF COMPLICATIONS BETWEEN THE TWO SUTURE TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606058 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention