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

Catalog Number	ERSD-320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
¿the human breast is not a sterile anatomic structure; it contains endogenous flora, derived from the nipple ducts, that is essentially similar to that found in normal skin.Multiple breast ducts provide a passage from the skin surface to deep within the breast tissue¿.(pittet et al, 2005).The origin of infection in women with implants remains difficult to determine, but potential sources include a contaminated implant, the surgery itself or the surgical environment, the patient's skin or mammary ducts, or, as suggested by many reports, seeding of the implant from remote infection sites.(pittet et al, 2005).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: ¿infection can occur with any surgery or implant.Most infections resulting from surgery appear within a few days to weeks after the operation.However, infection is possible at any time after surgery.In addition, breast and nipple piercing procedures may increase the possibility of infection.Infections in tissue with an implant present are harder to treat than infections in tissue without an implant.If an infection does not respond to antibiotics, the implant may have to be removed, and another implant may be placed after the infection is resolved".Also, a complete review of the dhr was carried out, no deviation was found in the process, so it is established that there is no evidence of a relationship between the event and the manufacturing process.No device returned confirmation has been provided so far.
Event or Problem Description
Usa- it was reported that a patient noted her left breast was swollen and the drainage was purulent.Planned for explant washout on (b)(6) 2025.No patients demographics, such as age, weight, or ethnicity, were provided by the reporter, and no adverse outcomes for the patients have been noted.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
1.Overview the quality department (pms) received a complaint involving a motiva® device.2.General conclusion device involvement: a causal relationship between the reported event and the device has not been established.Event characterization: the event was classified as not confirmed.Clinical confirmation upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported case was not confirmed.3.Technical investigation summary laboratory testing laboratory evaluation was conducted in accordance with wi-001048 "pms laboratory testing units." key findings include: visual inspection: the pms laboratory received the explanted unit, visual inspection of the implant revealed no observable physical damage, deformation, or structural defects as rupture/gel fracture.Root cause analysis this event 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 the alleged event is recognized as multifactorial, given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to the manufacturing process and/or the product itself.4.Device history record (dhr) review 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.Reference: phr section of the manufacturing documentation.5.Trend and signal monitoring 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 device rupture 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 ERGONOMIX ROUND SMOOTHSILK
• 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,alajuela ; 8003554164
• MDR Report Key: 22044692
• Report Number: 3012883202-2025-00699
• Device Sequence Number: 15680635
• Product Code: FTR
• UDI-Device Identifier: 07445161010575
• UDI-Public: (01)07445161010575(11)240809(17)290809
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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-320
• Device Lot Number: 24072208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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: Other
• Patient Sex: Unknown