MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Blood Loss (2597); 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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.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? citation: hip int 2015; 25 (6): 563-567; doi: 10.5301/hipint.5000278.(b)(4).

Event Description

It was reported via journal article ¿title: skin staples versus intradermal wound closure following primary hip arthroplasty: a prospective, randomised trial including 231 cases¿ author(s): martin a.Buttaro, mauricio quinteros, gabriel martorell, gerardo zanotti, fernando comba, francisco piccaluga citation: hip int 2015; 25 (6): 563-567; doi: 10.5301/hipint.5000278 this prospective randomized study was to present hypothesis that skin staples closure would have a similar complication rate and operative time as intradermal closure with polypropylene.From sep2011 to may2012, 219 patients (average age of 62 years) with 231 total hip arthroplasties (thas) were performed.Patients were divided into two groups for wound closure: staples group (n=105 patients with 112 thas) and intradermal group using continuous intradermal non-absorbable polypropylene suture ¿ prolene (n=115 with 119 thas).In all cases, deep fascia and deep subcutaneous fat tissue were closed using vicryl 0 sutures.Vicryl 2-0 was also used closure of superficial soft tissues in staples group only.In intradermal group, prolene 0 was used in would closure.During hospitalization, complications included haematoma (n=3 staple group, n=3 intradermal group), drain (n=2 staple group, n=1 intradermal group), bleeding (n=15 staple group, n=14 intradermal group), ecchymosis (n=7 staple group, n=13 intradermal group) and erythema (n=1 intradermal group).Post discharge, complications included haematoma (n=5 staple group, n=2 intradermal group), drain (n=2 staple group, n=1 intradermal group), deep infection (n=1 intradermal group), bleeding (n=4 staple group, n=4 intradermal group), ecchymosis (n=7 staple group, n=6 intradermal group) and erythema (n=2 staple group, n=5 intradermal group).There were also reported cases of wound dehiscence (n=4 cases), requiring no treatment.Also, there were two cases of cellulitis which were treated with empirical antibiotics, thromboembolic prophylaxis suspension and wound dressings.The patient from intradermal group who developed deep infection was treated with debridement and component retention, and received iv vancomycin 1g twice a day for 6 weeks; the patient recovered completely.The study minor complications in the staple group were doubled in comparison with the intradermal group.The complications could also be related to multiple factors coming from the patient, the surgery, the hospitalization or ambulatory period and not only the type of wound closure.The high incidence of minor complications reported in this study may reflect the prospective nature of data collection.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 7357695
• MDR Text Key: 103139898
• Report Number: 2210968-2018-71568
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention