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

Catalog Number	ERSD-425Q
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Physical Asymmetry (4573)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Australia.A patient implanted with motiva implants had a revision surgery due to capsular contracture (grade unknown), on the (b)(6) 2023 and the same implant was put back in.Patient had surgery on the (b)(6) for removal of the implant due to sitting high and a tight feeling.
Additional Manufacturer Narrative
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 (escudero et al., 2005).Breast prostheses are no different from any foreign material implanted into the human body in the sense of triggering a protective immune reaction from the host.This ¿foreign body response¿ (fbr) is universal and ideally removes or otherwise surrounds the ¿irritant material¿ with fibrous tissue to prevent unwanted immune sequelae.A capsule around a breast implant is, therefore, a necessary mechanism of body defense, but if excessive it can lead to pain and deformity of the breast (steiert, et al., 2013).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 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: ¿capsular contracture occurs when the capsule tightens and squeezes the implant.This can cause the implant to turn rigid (from slightly firm to quite hard) and the firmest ones can cause varying degrees of discomfort, pain, and palpability.In addition to the firmness, capsular contracture can result in a deformed breast, visible surface wrinkling and/or displacement of the implant.Detection of breast cancer by mammography may also be a more difficult.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.Patients should also be advised that additional surgery might be needed in cases where pain and/or firmness are severe (baker grades iii or iv) and that capsular contracture may happen again after additional surgeries."correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself¿.Malposition: "malposition of a breast implant is defined as an incorrect placement during surgery or its shifting from its original position.It is also called displacement/lateralization.Malposition has been a frequent event reported due to its multifactorial causes and it can be expected during the lifetime of the device.The implant¿s shifting can be produced by trauma, capsular contracture, gravity, or initially wrong placement1 the surgeon must plan the operation carefully and conduct the surgery with a technique that can minimize but not completely evade the risk of malposition.The risk associated with this event is dissatisfaction with aesthetic outcomes.In addition, a review of the device history record was conducted, and it was concluded that there were no deviations in the manufacturing process of this device that would have caused or contributed to this incident.
Additional Manufacturer Narrative
A relationship between the alleged events and the device involved could not be established.It was not possible to confirm the capsular contracture nor the malposition due to there was not enough clinical information available to support it.The alleged event is a risk associated with breast surgery and there is no evidence to suggest a link between this 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 the 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.Establishment labs will continue to monitor 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 ERGONOMIX ROUND SILKSURFACE WITH QID
• Common Device Name: MOTIVA IMPLANTS
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela ; 8003554164
• MDR Report Key: 21358504
• Report Number: 3012883202-2025-00358
• Device Sequence Number: 8482153
• Product Code: FTR
• UDI-Device Identifier: 07445161012210
• UDI-Public: (01)07445161012210(11)200304(17)250304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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 Expiration Date: 03/04/2025
• Device Catalogue Number: ERSD-425Q
• Device Lot Number: 20021499
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2020
• 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 Sex: Unknown