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

Catalog Number	ERSF-425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported experiencing breast firmness discomfort on her left breast.Physical examination and ultrasound surveillance revealed a rupture.The patient was advised to undergo breast implant removal surgery.No patient demographics, such as age, 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
As stated in the literature, ¿a number of risk factors for rupture have been identified; the most common cause is surgical instrument damage.¿ (handel et al., 2013).Additionally, rupture is a common and known reason for complaints, and it is clearly characterized in the product dfu included with the implant, as stated above.Additionally, no cases of rupture because of product failure have been reported to establishment labs ever.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: ¿breast implants can potentially remain intact for decades in the body, but all such devices will fail at some point.Breast implants rupture when the shell develops a tear or hole.Rupture can occur at any time after implantation, but it is most likely to occur; the longer the implant is in place.The following may cause implants to rupture: damage by surgical instruments, implant stress, and weakening during implantation, age and design of the implant, submuscular rather than sub-glandular location, the occurrence of post-operatory hematomas or seromas, folding or wrinkling of the implant shell, excessive force to the chest, trauma, compression during mammographic imaging, and severe capsular contracture¿.Establishment labs requested the unit to confirm the event and to perform the corresponding testing (including but not limited to: revision and characterization under the microscope of the rupture section, mechanical testing according to approved standards, etc.).It was informed that the patient/doctor has the unit, it was returned and is pending to be tested.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.
Additional Manufacturer Narrative
The reported device was returned for evaluation.There was a relationship between the reported event and the device.The initial visual inspection found a device rupture.Microscope inspection showed trace marks in the shell consistent with those of a sharp instrument reproduced in our laboratory, this is distinct from the pattern resulting from a spontaneous tear in the shell of the implant.Elongation tests confirmed the shell complied with the international specification standards.A complete review of the dhr for lot 21061157 was carried out, no deviation was found in the manufacturing process.Review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.In conclusion, it was determined that a probable cause for the event reported was a cut resulting from a sharp instrument used which could have weakened the shell establishment labs will continue to monitor for similar complaints/trends.
Event or Problem Description
South korea.A patient reported experiencing breast firmness discomfort on her left breast.Physical examination and ultrasound surveillance revealed a rupture.The patient was advised to undergo breast implant removal surgery.No patient demographics, such as age, 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; building b-25, coyol free zone; alajuela
• Manufacturer Contact: susana hidalgo ; coyol free zone, building b25; alajuela, CA 20113 ; CS 20113 ; 8003554164
• MDR Report Key: 20684359
• Report Number: 3012883202-2024-00116
• Device Sequence Number: 20648644
• Product Code: FTR
• UDI-Device Identifier: 07445161010797
• UDI-Public: (01)07445161010797(11)210622(17)260622
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2026
• Device Catalogue Number: ERSF-425
• Device Lot Number: 21061157
• 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: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2021
• 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 Sex: Unknown