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

Catalog Number	ERSM-275
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Physical Asymmetry (4573)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.It was reported that a patient who had her motiva implants on (b)(6) 2025, presents firm breast and displacement.She was diagnosed with a capsular contracture grade iii in her left breast.She will undergo explantation surgery.Efforts to gather additional information are ongoing and the investigation remains in progress.
Additional Manufacturer Narrative
As stated in literature: 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 placement.1 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.
Event or Problem Description
Usa.It was reported that a patient who had her motiva implants on (b)(6) 2025, presents firm breast and displacement.She was diagnosed with a capsular contracture grade iii in her left breast.She will undergo explantation surgery.Efforts to gather additional information were made and the investigation was completed.
Additional Manufacturer Narrative
A causal relationship between the reported event and the device has been established.Upon evaluation of the submitted clinical documentation and supporting evidence, the reported case was confirmed meeting the requirements for a capsular contracture, classified as baker grade iii/iv.This classification indicates moderate to severe contracture, characterized by firmness, distortion, and potential patient discomfort or pain.Malposition/displacement is also confirmed through the patient photographs provided.Capsular contracture is a well-documented complication inherent to breast implant surgery.Based on the analysis of the available data, including clinical findings and product traceability records, there is no evidence indicating a causal link between this specific case and any product-related factors, including raw materials or manufacturing processes.The etiology of capsular contracture is recognized as multifactorial, with potential contributing elements including postoperative patient-specific biological responses, and surgical technique.Given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to a defect in the device or its production.A comprehensive review of the device history record (dhr) for the affected lot was completed.No deviations, non-conformances, or anomalies were identified during manufacturing.All raw materials and process parameters conformed to specified quality requirements.The event has been evaluated as part of ongoing trend analysis activities within the pms program.Per the current complaint data report: no adverse or unexpected trends related to reported event have been identified.No further corrective or preventive actions are required at this time.Establishment labs will continue to monitor for similar events as part of routine pms surveillance.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: MOTIVA ERGONOMIX ROUND SMOOTHSILK
• 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,alajuela ; 8003554164
• MDR Report Key: 22701520
• Report Number: 3012883202-2025-00988
• Device Sequence Number: 13014543
• Product Code: FTR
• UDI-Device Identifier: 07445161010384
• UDI-Public: (01)07445161010384(11)240808(17)290808
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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
• Device Catalogue Number: ERSM-275
• Device Lot Number: 24072225
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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