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 Problem Wound Dehiscence (1154)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: (b)(4).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.Does the surgeon believe that any of the ethicon products involved (prineo or dermabond) caused and/or contributed to the post-operative complications (wound dehiscence, medication required, surgical intervention) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products (prineo or dermabond) used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via mw#2210968-2021-12763, mw#2210968-2021-12764, mw#2210968-2021-12765, mw#2210968-2021-12766, mw# 2210968-2021-12767, mw#2210968-2021-12768, mw#2210968-2021-12769, mw#2210968-2021-12770, mw#2210968-2021-12771, mw#2210968-2021-12772, mw#2210968-2021-12773, mw#2210968-2021-12774, mw#2210968-2021-12775, mw#2210968-2021-12776, mw#2210968-2021-12777, mw#2210968-2021-12778, mw#2210968-2021-12779, mw#2210968-2021-12780, mw#2210968-2021-12781, mw#2210968-2021-12782, mw#2210968-2021-12785, mw#2210968-2021-12786, mw#2210968-2021-127857, mw#2210968-2021-12788, mw#2210968-2021-12789, mw#2210968-2021-12790, mw#2210968-2021-12792, mw#2210968-2021-12793, mw#2210968-2021-12794, mw#2210968-2021-12795, mw#2210968-2021-12796, mw#2210968-2021-12797, mw#2210968-2021-12798, mw#2210968-2021-12799, mw#2210968-2021-12800.Citation: the journal of arthroplasty (2019); 34:1492-1497.Https://doi.Org/10.1016/j.Arth.2019.03.020.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: outcome of direct anterior total hip arthroplasty complicated by superficial wound dehiscence requiring irrigation and debridement the purpose of this retrospective study from a prospectively collected, single-institution joint registry was to examine the clinical outcomes of total hip arthroplasty (tha) performed through the direct anterior approach (daa) that required postoperative superficial irrigation and debridement (i&d).A total of 1573 patients (799 male and 774 female; mean age of 64 (19-97) years; mean bmi of 30 (14-60) kg/m2) who underwent tha using daa between august 26, 2010 and july 11, 2018 were included in the study.Either steri-strips with an overlying layer of dermabond (ethicon, somerville, new jersey) or dermabond prineo (ethicon, somerville, new jersey) was placed on the skin surface.Reported complications include superficial wound dehiscence (n=18) requiring superficial irrigation and debridement (i&d) and additional intravenous antibiotics/oral antibiotics in the following patients: (b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) male patient.(b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) male patient.(b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) female patient.(b)(6) male patient.(b)(6) female patient.(b)(6) female patient.In conclusion, superficial wound dehiscence requiring superficial i&d after daa tha occurs in about 1%-2% of patients and is more common in female patients and those with higher bmis.Superficial i&d is an effective treatment option for wound dehiscence with a low risk for subsequent pji.Patients can be expected to be satisfied with their tha with high clinical outcomes scores.In high-risk patients undergoing daa tha, extra care should be taken to respect the soft tissues, and when appropriate, a different approach should be utilized to avoid this complication.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• 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
• MDR Report Key: 13049397
• MDR Text Key: 287819488
• Report Number: 2210968-2021-12791
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: 11/23/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female