MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a clinical trial; 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.Was the case discussed in this study 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 study? does the surgeon believe there was any deficiency with the ethicon product involved? what was the date of the initial procedure? how was the diagnosis of cellulitis made? were any cultures performed of the wound? if so, what are the results? what is the surgeon opinion as to relationship of the stratafix, vicryl or monocryl suture and the patient symptoms? what is the current condition of the patient?.

Event Description

It was reported via clinical trial: (b)(6): the broad aim of this study was to compare the safety and efficacy of using barbed sutures versus standard of care sutures for closure of arthrotomy during total knee arthroplasty.A total of 60 patients undergoing total knee arthroplasty were enrolled in a prospective, blinded trial and randomized to receive either running closure of the arthrotomy with barbed sutures (n=30) or interrupted closure with standard of care sutures (n=30).A 16 centimeter medial para-patellar tka approach was planned on all patients.All closures were performed in 3 layers, with the knee in approximately 90° of flexion to minimize potential imbrication of the capsule.For the standard of care group, the arthrotomy (deep layer) was repaired using number 1-0 braided, absorbable suture (vicryl, polyglactin 910, ethicon, johnson & johnson, somerville, nj) followed by closure of the intermediate layer with a 2-0 braided absorbable sutures (vicryl, polyglactin 910, ethicon, johnson & johnson, somerville, nj) and a subcutaneous layer with a 2-0 monofilament (monocryl, polyglecaprone 25, ethicon, johnson & johnson, somerville, nj) followed by adhesive strips (steri-strips¿, 3m, maplewood, mn) followed by surgical dressing (aquacel ¿, convatech, deeside, united kingdom) that was removed at post-operative day 7.For the barbed suture group, wound closure was performed similarly in 3 layers with the use of barbed for closure of the capsule (stratifix symmetric polydioxanone plus #1, ethicon, johnson & johnson, somerville, nj) (table 2).The subcutaneous layer was then closed with simple interrupted knots using number 2-0 braided absorbable sutures followed by closure of the subcutaneous layer using a number 4-0 monofilament absorbable suture with inverted interrupted knots.Finally, the adhesive strips followed by surgical dressing were applied.These were both removed at post-operative day 7.This file will capture the superficial surgical site infection in the barbed suture group.The patient was a (b)(6) man in the barbed suture group with a history of hemochromatosis and diabetes without complications who presented to his primary care physician on postoperative day 2 with complaints of pain and redness.Physical exam showed erythema in peri-incisional distribution consistent with post-operative cellulitis.He was prescribed sulfamethoxazole-trimethoprim 800-160 mg taken orally twice daily for ten days as well as cephalexin, 250 mg, four-times daily over ten days and advised to wear compression stocking.His symptoms abated by the end of the course of antibiotics and he had no further episodes.

• Brand Name: STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8454589
• MDR Text Key: 139981792
• Report Number: 2210968-2019-79708
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AQUACEL; KNEE JOINT; STERI STRIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR