MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.

Event Description

It was reported in a journal article entitled: skin closure with 2-octyl-cyanoacrylate and polyester mesh after primary total knee arthroplasty offers superior cosmetic outcomes and patient satisfaction compared to staples: a prospective trial.The aim of this prospective study was to compare the outcomes of patients receiving 2-octyl-cyanoacrylate glue and polyester mesh for skin closure after total knee arthroplasty (tka) versus staples for the following outcomes at 6- and 12 weeks postoperative: (1) visual analog scale (vas) patient satisfaction with wound cosmesis per tka and (2) wound-related complications per tka, including stitch abscess, wound hematoma, wound dehiscence, superficial surgical site infection (ssi), deep ssi, and periprosthetic joint infection (pji), readmission, and reoperation.Between january 15, 2018 to february 27, 2019, 54 patients undergoing 60 tkas were included in the study that were divided into two group: 30 tkas (male=8, female=22; mean age=62 ± 8 years; mean bmi=33 ± 5.2 kg/m^2) were under glue and polyester-mesh group, and 30 patients (male=15, female=15; mean age=62 ± 7 years; mean bmi=35 ± 7.5 kg/m^2) were under control group.For the glue and polyester mesh group, closure of the subcutaneous layer was performed using a unidirectional barbed number 4-0 monofilament absorbable suture (stratafix, number 4 monofilament suture, ethicon) with inverted interrupted knots.The skin edges were approximated using adhesive polyester mesh (prineo, ethicon).2-octyl cyanoacrylate (glue) (dermabond, ethicon) was applied in a single layer on the polyester mesh and allowed to dry for a minimum of thirty seconds.The wound was then covered with surgical dressing.The polyester mesh was removed during the 4-week post-operative visit.In the glue and polyester mesh group, a (b)(6) year old male patient had superficial ssi.On his post-operative day-4, he required readmission for treatment of severe cellulitis.He left against medical advice before he received intravenous antibiotics and required a second readmission for insert of a peripherally inserted central catheter (picc) line.Ultimately, the patient successfully completed an intravenous course of antibiotics.In conclusion, the skin closure with polyester mesh and glue offers superior patient satisfaction and cosmetic outcomes compared to staples for wound closure in tka patients.

Manufacturer Narrative

Product complaint#: (b)(4).

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9434286
• MDR Text Key: 185547469
• Report Number: 2210968-2019-90629
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 12/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR