BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

    MDR report key: 9198292 · Received October 16, 2019

    Report

    Report Number
    2210968-2019-88729
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION HAVE BEEN MADE WITH NO RESPONSE TO DATE. 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? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 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: ORTHOPEDICS. 2018; 41(2):E262-E267; DOI: 10.3928/01477447-20180213-05. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: THE EFFECTS OF PLATELET-RICH PLASMA AND ACTIVATED COLLAGEN ON WOUND HEALING IN PRIMARY TOTAL JOINT ARTHROPLASTY. AUTHOR/S: ALDO BOVE,DAVID C. EVANS, BA; BRUCE G. EVANS, MD. CITATION: ORTHOPEDICS. 2018; 41(2):E262-E267; DOI: 10.3928/01477447-20180213-05. THE OBJECTIVE OF THIS (B)(6) STUDY WAS TO DETERMINE WHETHER ADDITIVES WOULD IMPROVE WOUND OUTCOMES AND PREVENT POSTOPERATIVE COMPLICATIONS IN PRIMARY TOTAL KNEE AND TOTAL HIP SURGERIES. A TOTAL OF 90 PATIENTS WITH OSTEOARTHRITIS UNDERWENT ELECTIVE PRIMARY TOTAL KNEE OR TOTAL HIP ARTHROPLASTY AND WERE RANDOMIZED INTO THREE GROUPS: GROUP 1 (N=30; N=10 MALE AND N=20 FEMALE; AVERAGE BODY MASS INDEX [BMI] OF 28.2±6.7 KG/M^2) ¿ RECEIVING PLATELET-RICH PLASMA (PRP) PRIOR TO WOUND CLOSURE; GROUP 2 (N=30; N=13 MALE AND N=17 FEMALE; AVERAGE BMI OF 32±8.1 KG/M^2) ¿ RECEIVING ACTIVATED COLLAGEN PRIOR TO WOUND CLOSURE; AND GROUP 3 (N=30; N=13 MALE AND N=17 FEMALE; AVERAGE BMI OF 28.3±5.7 KG/M^2) ¿ ACTED AS CONTROL (WITHOUT ADDITIVE). IN ALL PATIENTS, DERMABOND PRINEO SKIN CLOSURE SYSTEM (ETHICON) WAS USED IN SKIN CLOSURE. POSTOPERATIVELY, OVERALL OUTCOMES INCLUDED ERYTHEMA (N=21 AT 2 WEEKS; N=4 AT 6 WEEKS), INDURATION (N=10 AT 2 WEEKS; N=2 AT 6 WEEKS), SWELLING (N=39 AT 2 WEEKS; N=8 AT 6 WEEKS), WOUND SEPARATION (N=2 AT 2 WEEKS; N=5 AT 6 WEEKS) WHICH REQUIRED IRRIGATION AND CLOSURE IN ONE PATIENT, TISSUE NECROSIS (N=8 AT 2 WEEKS; N=3 AT 6 WEEKS); ELEVATED SCAR (N=5 AT 6 WEEKS); AND SUPERFICIAL WOUND INFECTION (N=12 AT 6 WEEKS) CLEARED WITH ANTIBIOTICS IN ALL AND ONE PATIENT REQUIRED IRRIGATION AND DEBRIDEMENT WITH CLOSURE OVER DRAINS. ON THE BASIS OF THIS STUDY, THESE ADDITIVES ARE NOT RECOMMENDED FOR ROUTINE PRIMARY JOINT ARTHROPLASTY; HOWEVER, THE DATA SUGGEST POSSIBLE BENEFITS FOR HIGH-RISK PATIENTS AND THOSE FOR WHOM BLOOD LOSS MAY BE AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994183 PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention