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U.S. Department of Health and Human Services

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

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Impaired Healing (2378)
Event Date 08/02/2021
Event Type  Injury  
Event Description
Title: direct anterior approach for total hip arthroplasty using the ¿bikini incision¿ the aim of this prospective series is to highlight the technical aspects of the ¿bikini¿ incision in daa arthroplasty and show how it can safely be applied¿even in obese patients. A total of 532 consecutive patients undergoing 613 primary total hip arthroplasty (tha) with a bikini incision between january 1 and december 31, 2017 were included. The skin incision, located three fingerbreadths distal to the anterior superior iliac spine (asis), is orientated parallel to the groin crease. One third of the incision is medial and two thirds lateral to the asis. Subcutaneous dissection should only be performed in the lateral two thirds of the incision to protect the main branches of the lateral femoral cutaneous nerve (lfcn). The fascia lata is opened as far lateral over the muscle belly as possible to leave the lfcn untouched within its fascial sheet. The stepwise procedure consists of three key steps: capsular exposure, capsular release, and component insertion. The approach allows for an excellent 360° exposure of the acetabulum. The femur is aligned along the incision during femoral elevation and adduction. With this technique, daa hip arthroplasty can be performed in a lessinvasive way providing best possible functional and cosmetic outcomes. The lateral cutaneal nerve is shownmedial to the fascia incision (indicatedwith the forceps). During the entire procedure, it should remain untouched within its fascial sheet. In case the fascial closure remains close enough to the fascia edges, there is aminimal risk of violating the lateral femoral cutaneous nerve (lfcn)]. The skin is closed with vicryl 1 subdermal closure and skin glue (dermabond¿ prineo¿, johnson&johnson). Cosmetic bikini incision shown 6months after surgery. Reported postoperative complications included n
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2 bleeding, n
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8 hematoma, n
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4 prolonged wound drainage, n
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3 revision, n
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8 readmission and n
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1 superficial infection. In conclusion, these studies demonstrate that daa arthroplasty through the ¿bikini¿ incision can result in good clinical outcomes with a low rate of wound complications. It has further been shownthat evenhighlyobese patients can benefit from daa tha via the ¿bikini¿ incision.
 
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. 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 caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products 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. Patient demographics? 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. (b)(4). The single complaint was reported with multiple events. There are no additional details regarding the additional events. Related events captured 2210968-2021-12753. Citation: oper orthop traumatol 2021 · 33:318¿330. Https://doi. Org/10. 1007/s00064-021-00721-y.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL 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 Key13043068
MDR Text Key287270242
Report Number2210968-2021-12752
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation
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 Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2021 Patient Sequence Number: 1
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