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

Model Number	3542507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent breast augmentation procedure with a 250cc mentor memorygel breast implant and experienced left side capsular contracture; baker grade iii.As a result, the device was explanted on an unknown date.
Additional Manufacturer Narrative
Photo evaluation summary: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.It should be noted that 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, capa activity was not required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 6, 2023, the mentor failure analysis lab received the device for evaluation.Following information has been updated on this form as per paperwork received with the device.Patient's initials under field a! has been updated to (b)(6).Date of birth under field a2 has been updated to (b)(6) 1976 ; month and year was received patient underwent revision breast augmentation mentor became aware that patient experienced bilateral capsular contracture; baker grade iii, and underwent bilateral replacement surgery with catalog number smpx190; serial number (b)(6) on the left side, and with catalog number smpx190; serial number (b)(6) on july 4, 2023.This supplemental report is for the left side.Right side complication is being reported separately date of explant under field d6b has been updated to (b)(6), 2023 on this form on september 8, 2023, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the gel siltex mod-rnd 250cc returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.It should be noted that 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, capa activity was not required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.On september 10, 2023, mentor became aware that incorrect due date "8/12/2023" was mistakenly submitted under previous initial submission.It should have been "8/11/2023" manufacturer¿s reference number: (b)(4).Incorrect due date "8/12/2023" was mistakenly submitted under previous initial submission.

• Brand Name: MENTOR MEMORYGEL 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: 17368660
• Report Number: 1645337-2023-08639
• Device Sequence Number: 11708520
• Product Code: FTR
• UDI-Device Identifier: 00081317000655
• UDI-Public: 00081317000655
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Expiration Date: 04/11/2010
• Device Model Number: 3542507
• Device Catalogue Number: 3542507
• Device Lot Number: 5597548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2005
• 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: 46 YR
• Patient Sex: Female