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

Catalog Number	SMHX545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Reason for device explant and/or reoperation: left capsular contracture; baker grade iii.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 female patient underwent breast augmentation with 545cc mentor memorygel xtra breast implant on the left side and experienced bilateral capsular contracture; baker grade iii.As a result, the patient underwent bilateral replacement surgery with catalog number smhx375; serial number (b)(6) on the left side, and with catalog number smhx375; serial number (b)(6) on the right side on (b)(6), 2025.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On may 8, 2025, photo evaluation was completed as follows: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture 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 according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: 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.Field d4 for udi information has been updated to "(b)(4)" on this form.This was missing in previous report.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 24, 2025, the mentor failure analysis lab received the device for evaluation.On july 6, 2025, device evalauation was completed as follows: during the visual evaluation, no apparent damage or visual anomalies were observed on the smooth mod high xtra, 545cc returned device.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture 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 according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: 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.This supplemental medwatch report is for the patient¿s left-sided device.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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 21910101
• Report Number: 1645337-2025-04410
• Device Sequence Number: 18341599
• Product Code: FTR
• UDI-Device Identifier: 10081317027895
• UDI-Public: 10081317027895
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SMHX545
• Device Lot Number: 9842737
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/24/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/21/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female