MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SMPX560
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Breast Mass (2439)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: collapsed breast.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 36-year-old caucasian female patient underwent a primary breast augmentation with two 560cc mentor memorygel xtra breast implants and experienced bilateral local reactions and bilateral rupture post-operatively.The patient mentioned having swelling and pain issues as well as less fullness and indentations.The patient also reported having a previous surgical intervention on the left side; the healthcare provided had to add a mesh on the left side as the left breast was ¿collapsed¿.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left side device.
Additional Manufacturer Narrative
On may 08, 2024, mentor received additional information regarding the event.It was reported that the patient underwent device explantation on (b)(6) 2024.Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Reason for device explant and/or reoperation: collapsed breast, local reaction, and breast mass.It was also reported that the patient's right breast prosthesis was confirmed to be ruptured; not the patient's left side.On may 15, 2024, mentor received additional information regarding the patient's mri results.It was reported that the patient had a breast mass on the left side.The breast mass was suggestive of a fibroadenoma.All relevant information has been updated on this report to capture this additional information.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2024, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 26, 2024, the evaluation for the device was completed.Device evaluation summary: during visual evaluation, no apparent damage or visual anomalies were observed on the smooth mod + prof xtra 560cc returned device.Swelling is a temporary normal post-operative condition.Depending on presentation, delayed swelling may require additional work-up by the surgeon.Swelling is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19038670
• Report Number: 1645337-2024-04111
• Device Sequence Number: 7242389
• Product Code: FTR
• UDI-Device Identifier: 00081317025122
• UDI-Public: 00081317025122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 09/10/2025
• Device Catalogue Number: SMPX560
• Device Lot Number: 9498660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/08/2024; 06/05/2024; 06/26/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/30/2024; 06/24/2024; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2020
• 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: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White