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

Catalog Number	ERSF-450
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Cyanosis (1798); Seroma (2069)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
United states.It was reported that a 38 year old patient who had a mastopexy with motiva implants presented a frank purulent fluid coming out from her breasts.She was advised to undergo implant removal surgery.No patient demographics, such as weight or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
As stated in literature: ¿early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.¿ (sforza, et al.2017).Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: seroma: "seroma is a build-up of fluid around the implant.Having a hematoma and/or seroma following surgery may result in a future infection and/ or capsular contracture.Symptoms from a hematoma or seroma may include swelling, pain, and bruising.If a hematoma or seroma occurs, it will usually be soon after surgery.However, this can also occur at any time after injury to the breast.While the body absorbs small hematomas and seromas, some will require surgery, typically involving draining and potentially placing a temporary surgical drain in the wound for proper healing.A small scar can result from surgical draining.Implant rupture can also occur from surgical draining if there is damage to the implant during the draining procedure".Implant removal: "patients should be advised that implants are not considered lifetime devices, and they will potentially undergo implant removal, with or without replacement, throughout their life.Patients should also be advised that the changes to their breasts following explantation might be irreversible".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 reported event and the device could not be established.It was not possible to confirm the condition reported due to lack of clinical evidence.No defect/damage was found on the units upon visual inspection.A complete review of the dhr for lot 24072280 was carried out, no deviation was found in the manufacturing process.The review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.¿ a definitive root cause could not be determined.Potential factors nonrelated to the manufacture of the device that may lead to the event reported include but are not limited to: (1) surgical factors.¿ units returned for evaluation did not present any damage.¿ as no manufacturing, material or design issues were identified, no further investigation or additional actions are required at this time.¿ establishment labs will continue to monitor for similar complaints/trends.

• 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: 21411655
• Report Number: 3012883202-2025-00383
• Device Sequence Number: 13155745
• Product Code: FTR
• UDI-Device Identifier: 07445161010803
• UDI-Public: (01)07445161010803(11)240812(17)290812
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: ERSF-450
• Device Lot Number: 24072280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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 Age: 38 YR
• Patient Sex: Unknown