BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 7034966 · Received November 15, 2017

    Report

    Report Number
    2210968-2017-71256
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    June 11, 2014
    Report Date
    October 25, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? CITATION: J ORTHOPAED TRAUMATOL (2015) 16:59¿65. DOI 10.1007/S10195-014-0300-4. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿SUTURE-RELATED PSEUDOINFECTION AFTER TOTAL HIP ARTHROPLASTY¿ THAT THE PATIENT UNDERWENT CEMENTLESS CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY (THA) AND SUTURE WAS USED. IN THE 9TH WEEK FROM INDEX SURGERY, THE PATIENT STARTED TO COMPLAIN OF TENDERNESS, WARMTH AND REDNESS OF THE SKIN AROUND THE SCAR. EXAMINATION SHOWED MINIMAL SEROPURULENT DISCHARGE FROM A SMALL SINUS. BLOOD TESTS DETECTED MILDLY ELEVATED CRP AND ERYTHROCYTE SEDIMENTATION RATE (ESR). ULTRASONOGRAPHIC (US) EXAM OF THE HIP DEMONSTRATED AN ABSCESS IN THE DEEP LAYER OF THE HYPODERMIS WITH SEVERAL SINUS TRACTS TOWARD THE SURFACE. DEBRIDEMENT WAS PERFORMED THROUGH THE PRE-EXISTING SCAR, WITH EXCISION OF MULTIPLE SINUS TRACTS. A MASSIVE ABSCESS, WITH PURULENT GREY-YELLOWISH CONTENT, WAS RETRIEVED, THE CAVITY DEBRIDED AND IRRIGATED WITH DILUTED IODOPOVIDONE AND SALINE SOLUTION. THOROUGH IRRIGATION WAS PERFORMED AFTER MICROBIOLOGICAL SAMPLING, THE WOUND WAS CLOSED WITH PLACEMENT OF 2 SUCTION DRAINS, AND ANTIBIOTIC THERAPY WAS STARTED. NO CULTURES WERE POSITIVE. HISTOLOGICAL EXAMINATION OF THE COLLECTED MATERIAL DEMONSTRATED A GIANT-CELL FOREIGN-BODY REACTION. 8 WEEKS AFTER IRRIGATION AND DRAINAGE, THERE WAS MILD CRP ELEVATION WITH MINIMAL SCAR INFLAMMATION AND SUTURE MATERIAL EXTRUSION. THE WOUND WAS TREATED WITH IODOPOVIDONE SOLUTION AND DAILY DRESSING CHANGE AND HEALED IN A WEEK AFTER COMPLETE EXTRUSION OF THE FOREIGN MATERIAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811328 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention