MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

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

Patient Problems Pulmonary Embolism (1498); Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Joint Dislocation (2374); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported via journal article: title: the fate of the patient with superficial dehiscence following direct anterior total hip arthroplasty.The objective of this study is to evaluate patient risk factors, reoperations, and revisions in those who developed superficial wound dehiscence following daa tha.Between january 1, 2010 to december 31, 2019, a total of 3,687 patients who underwent a primary direct anterior approach (daa) total hip arthroplasty (tha).Of these, 98 patients (63 females and 35 males) developed a superficial wound dehiscence requiring intervention [irrigation and debridement or wound care with or without antibiotics.Dehiscence was noted at a median of 27 (range, 2-105) days.Patients who had superficial wound dehiscence compared to those who did not, were more often women and had increased mean body mass index.In total, there were three reoperations and two revisions in the superficial dehiscence group.There was one nonrevision reoperation which was an arthroscopic iliopsoas tenotomy for liopsoas impingement.The indications for revision were femoral aseptic loosening (1) and pji (1).Two patients did require a repeat i and d for their superficial dehiscence, but eventually healed their incision uneventfully.Two patients did require a repeat i and d for their superficial dehiscence, but eventually healed their incision uneventfully.There were two additional complications not leading to reoperation: one dislocation managed with closed reduction and one pulmonary embolism managed medically.There were 21 revisions in the no dehiscence cohort for pji.Three cases were polymicrobial skin flora.There were two cases which speciated pseudomonas aeruginosa and two cases which speciated serratia marcescens.There was one case of cutibacterium avidum.Final closure was performed with a running subcuticular absorbable monofilament and the incision was dressed with either steri-strips (3m, st.Paul, minnesota) and dermabond (ethicon, somervile, new jersey) or with a dermabond prineo (ethicon, somervile, new jersey) dressing.Reported complications include liopsoas impingement (n=1), femoral aseptic loosening (n=1), pji/periprosthetic joint infection (n=1), dislocation (n=1), pulmonary embolism (n=1), polymicrobial skin flora (n=3), pseudomonas aeruginosa (n=2), serratia marcescens (n=2) and cutibacterium avidum (n=1).In conclusion, superficial wound dehiscence following daa tha was associated with higher body mass index and was more common in women.Fortunately, with proper index management, the risk of revision tha and periprosthetic joint infection was not increased for these patients.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.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 any of the ethicon products involved (dermabond & prineo) caused and/or contributed to the post-operative complications: liopsoas impingement, femoral aseptic loosening, pji/periprosthetic joint infection, pulmonary embolism, polymicrobial skin flora, pseudomonas aeruginosa, serratia marcescens , cutibacterium avidum, described in the article? does the surgeon believe there was any deficiency with any of the ethicon products (dermabond & prineo) used in this procedure? if so, please provide details.Which specific ethicon products (dermabond & prineo) have been used during the procedures (product code, lot number)? patient demographics? the single complaint was reported with multiple events.There are no additional details regarding the additional events.No product available for return.Citation: the journal of arthroplasty xxx (2023) 1e6// https://doi.Org/10.1016/j.Arth.2023.04.044.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18793388
• MDR Text Key: 336399255
• Report Number: 2210968-2024-02035
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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