MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; ERGONOMIX ROUND SILKSURFACE

Catalog Number	ERSD-360
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Korea- it was reported that a patient complaint about a firmness and asymmetry in her right breast.She was diagnosed with a capsular contracture baker grade iv unilateral right breast ((b)(6)).
Additional Manufacturer Narrative
Quality department (pms) has received a complaint regarding a device from establishment labs, additional information provided in the "details" section.After an analysis of the clinical evidence provided and the report, it was possible to confirm the alleged event.The alleged event is a risk associated with breast surgery and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of occurrence.The cause of this event is multifactorial, and we cannot conclude that the reported event was caused by the manufacturing process and/or the product itself.A complete review of the dhr for lot involved was carried out, no deviation was found in the manufacturing process.Additionally, there were no indications of abnormalities in raw materials or manufacturing processes which may have affected this particular batch.-the instructions for use in the directions for use were reviewed, to determinate if there are indications that ensure the prevention and good handling of the product.For this event, it is considered that the information is suitable for the section of surgical precautions as follows: capsular contracture - "a capsular contracture pertains to hypertrophic scar tissue investing in a foreign body or surgically implanted device, compromising the aesthetic outcome, resulting in pain, breast deformity, and often necessitating further operations4.Detection of breast cancer by mammography may also be challenging.Capsular contracture may be more common following infection, hematoma and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery.Capsular contracture is the most common complication following implant- based breast surgery and is one of the most common reasons for reoperation".Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: information for the patient¿ during her surgical consultation, it is the surgeons´ responsibility to ensure that the patient completely understands the information regarding the risks, benefits, and recommendations associated with silicone gel-filled breast implant surgery, as well as the complications typical of any type of surgery.This document is available in motiva® website: ifu.Motiva.Health.The most common overall indication for reoperation is capsular contracture.(handel, 2006).Capsular contracture produces asymmetry between both breasts either in bilateral (when the degree of affectation is different) or unilateral cases.The patient may present discomfort in the contracting breasts, such as coldness and pain.(f.J.Escudero et al., 2005).Capsular contracture occurs approximately five times more frequently with smooth surface implants compared with textured surface implants.(barnsley, et al.2006).Establishment labs will continue to monitor for similar complaints/trends.As part of the post market surveillance process, monitoring of the primary endpoints reported is performed to determine unfavorable trends.Per our current complaint data report, no unfavorable trends were detected on this product.No further actions are required.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: ERGONOMIX ROUND SILKSURFACE
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113 ; 8003554164
• MDR Report Key: 22079960
• Report Number: 3012883202-2025-00730
• Device Sequence Number: 8702692
• Product Code: FTR
• UDI-Device Identifier: 07445161010599
• UDI-Public: (01)07445161010599(11)230104(17)280104
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: ERSD-360
• Device Lot Number: 22122481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female