BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 7035114 · Received November 15, 2017

    Report

    Report Number
    2210968-2017-71257
    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

    (B)(4). 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. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE VICRYL PLUS SUTURE USED IN THIS PROCEDURE? 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.

    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 8TH WEEK AFTER THA, THE PATIENT STARTED COMPLAINING OF TENDERNESS, WARMTH AND REDNESS OF THE SCAR, WITH MILD ELEVATIONS OF BODY TEMPERATURE (37.5C). AMBULATION BECAME PAINFUL AS WELL AS LYING ON THE OPERATED SIDE. THE PATIENT WAS SEEN 3 DAYS AFTER SYMPTOM ONSET WITH EXTREMELY PAINFUL SCAR ON PALPATION. BLOOD TESTS DETECTED MILDLY ELEVATED CRP AND ESR. US EXAMINATION OF THE HIP DEMONSTRATED A BULKY PERTROCHANTERIC ABSCESS WITH SEVERAL SINUS TRACTS PERFORATING THE FASCIA TOWARDS THE SURFACE. DEBRIDEMENT WAS PERFORMED THROUGH THE PRE-EXISTING SCAR AND A MASSIVE ABSCESS, WITH PURULENT GREY-YELLOWISH MATERIAL WAS RETRIEVED. SEVERAL FISTULAE PERFORATED THE FASCIA AND ALLOWED THE EXUDATES TO SPREAD IN THE PERTROCHANTERIC SPACE. AFTER CULTURE AND HISTOLOGIC SAMPLING, THE CAVITY WAS DEBRIDED AND IRRIGATED WITH IODOPOVIDONE AND SALINE SOLUTION. THE FASCIA WAS INCISED, TRANS-FASCIAL FISTULAE EXCISED AND THE PERTROCHANTERIC SPACE DEBRIDED AND IRRIGATED SIMILARLY. THE PROCEDURE WAS COMPLETED WITH MICROBIOLOGICAL SAMPLING, CAREFUL JOINT IRRIGATION AND STARTING ANTIBIOTIC THERAPY. NO CULTURES WERE POSITIVE. HISTOLOGICAL EXAMINATION OF THE MATERIAL COLLECTED SHOWED PATTERN OF FOREIGN BODY REACTION. FIVE WEEKS AFTER REOPERATION, THERE WAS ELEVATED CRP ASSOCIATED WITH SUTURE MATERIAL EXTRUSION. FREQUENT WOUND CARE ALLOWED COMPLETE RECOVERY AND RENORMALIZATION OF CRP WITHIN 2 WEEKS, WITHOUT ANY FURTHER RECURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812966 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention