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

Catalog Number	ERSD-320
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported experiencing hardening and pain in her left breast.Physical examination an ultrasound report revealed capsular contracture baker grade iii.The patient was advised to undergo breast implant removal surgery.No patient demographics, weight, or ethnicity, were provided by the reporter, and no adverse outcomes for the patient have been noted.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
¿ a clinical evaluation of the report and evidence provided was executed and a unilateral capsular contracture baker grade iii was confirmed.No defect/damage was found in the unit received upon visual inspection.A complete review of the dhr for lot 22101284 was carried out, no deviation was found in the manufacturing process.Additionally, the review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.¿ a clinical evaluation of the report and evidence provided was executed and a capsular contracture baker grade iii was confirmed.No defect/damage was found in the unit received upon visual inspection.A complete review of the dhr for lot 22101284 was carried out, no deviation was found in the manufacturing process.Additionally, the review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.¿ 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: "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 operations.4.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" ¿ potential factors unrelated to the design or manufacture of the device that may lead to capsular contracture, include but are not limited to: (1) patient undergoing revision surgery.(2) previous infection, hematoma and/or seroma.(3) patient has previous history of capsular contracture.(4) surgical factors.¿ 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.
Event or Problem Description
South korea.A patient reported experiencing hardening and pain in her left breast.Physical examination an ultrasound report revealed capsular contracture baker grade iii.The patient was advised to undergo breast implant removal surgery.No patient demographics, weight, or ethnicity, were provided by the reporter, and no adverse outcomes for the patient have been noted.Efforts to gather additional information were made, and the investigation was completed.

• Brand Name: MOTIVA ERGONOMIX ROUND SILKSURFACE
• Common Device Name: MOTIVA ERGONOMIX
• Manufacturer (Section D): ESTABLISHMENT LABS S.A; coyol free zone, building b25; alajuela CA ; CS
• Manufacturer (Section G): ESTABLISHMENT LABS S.A; building b-25, coyol free zone; alajuela
• Manufacturer Contact: susana hidalgo ; coyol free zone, building b25; alajuela, CA ; CS ; 8003554164
• MDR Report Key: 20683795
• Report Number: 3012883202-2024-00114
• Device Sequence Number: 7441063
• Product Code: FTR
• UDI-Device Identifier: 07445161010575
• UDI-Public: (01)07445161010575(11)221018(17)271018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 22101284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female