BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8693403 · Received June 12, 2019

    Report

    Report Number
    2210968-2019-82686
    Event Type
    Injury
    Date Received
    June 12, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: INJURY, INT. J. CARE INJURED. 2017; 48: 2248¿2252. DOI: HTTP://DX.DOI.ORG/10.1016/J.INJURY.2017.06.018. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: STAGED RECONSTRUCTION OF DIAPHYSEAL FRACTURES WITH SEGMENTAL DEFECTS: SURGICAL AND PATIENT-REPORTED OUTCOMES". AUTHOR(S): S.D. ZOLLER, L.A. CAO, R.A. SMITH, W. SHEPPARD, E.L. LORD, C.D. HAMAD, J.H. GHODASRA, C. LEEA, D. JEFFCOAT. CITATION: INJURY, INT. J. CARE INJURED. 2017; 48: 2248¿2252. DOI: HTTP://DX.DOI.ORG/10.1016/J.INJURY.2017.06.018. TWO-STAGE LIMB RECONSTRUCTION IS AN OPTION FOR PATIENTS WITH CRITICAL SIZE SEGMENTAL BONE DEFECTS FOLLOWING ACUTE TRAUMA OR NON-UNION. RECONSTRUCTION IS TECHNICALLY DEMANDING AND ASSOCIATED WITH A HIGH COMPLICATION RATE. CURRENT PROTOCOLS FOR LIMB RECONSTRUCTION HAVE WELL-DOCUMENTED CHALLENGES, AND NO STUDY HAS REPORTED ON PATIENT OUTCOMES USING A VALIDATED QUESTIONNAIRE. IN THIS STUDY, THE AUTHORS AIMED TO EXAMINE THE CLINICAL AND PATIENT-CENTERED OUTCOMES FOLLOWING OUR SURGICAL PROTOCOL FOR TWO STAGE LIMB RECONSTRUCTION FOLLOWING CRITICAL SIZE SEGMENTAL DEFECTS. A SINGLE SURGEON PERFORMED RECONSTRUCTION OF LONG BONE DEFECTS USING ANTIBIOTIC IMPREGNATED CEMENT SPACERS AND INTRAMEDULLARY CANCELLOUS BONE AUTOGRAFT. A RETROSPECTIVE CHART REVIEW WAS PERFORMED IN 10 LIMBS REPRESENTING 9 PATIENTS (AGE RANGE: 22 TO 53 YEARS OLD; 8 MALE AND 1 FEMALE PATIENT) WERE INCLUDED. DURING THE SURGICAL PROCEDURE, AUTOGRAFT IS GENERALLY USED ALONE, BUT IF A SINGLE FEMUR DOES NOT PROVIDE ADEQUATE GRAFT MATERIAL, IT IS MIXED WITH CANCELLOUS ALLOGRAFT, AND THE MIXTURE IS IMPLANTED WITHIN THE MEMBRANE SPACE. THE MEMBRANE IS CLOSED WITH ABSORBABLE VICRYL SUTURE (ETHICON), AND THE WOUND IS CLOSED IN LAYERS. REPORTED COMPLICATIONS INCLUDED PATIENT (B)(6), A (B)(6) FEMALE PATIENT WITH INFECTION AND NON-UNION, PATIENT (B)(6), A (B)(6) FEMALE PATIENT WITH INFECTION AND NON-UNION, PATIENT (B)(6), A (B)(6) MALE PATIENT WITH INFECTION, PATIENT (B)(6), A (B)(6) MALE PATIENT WITH INFECTION, INFECTION (N-5), AND NON-UNION (N-3) IN WHICH 2 OF THE 3 CASES WENT ON TO FULL UNION AFTER ADDITIONAL PROCEDURES AND 1 PATIENT REQUIRED AMPUTATION. THIS STUDY HAS IDENTIFIED OUR EXPERIENCES WITH THE TWO-STAGE TECHNIQUE FOR RECONSTRUCTION OF LONG BONE DEFECTS. SURGICAL ANDPATIENT-REPORTED OUTCOMES IN THIS SMALL PATIENT COHORT WERE ACCEPTABLE, DESPITE RISKS OF COMPLICATION AND THE LONG INTERVAL TO UNION AND WEIGHTBEARING. THERE IS AN ASSOCIATION BETWEEN INFECTION AND NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487353 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention