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

Catalog Number SMHX400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Capsular Contracture (1761)

Event Date 01/10/2024

Event Type  Injury  

Event Description

It was reported that a patient implanted with a 375cc (left), 400cc (right), mentor memorygel xtra breast implant experienced bilateral capsular contracture (baker grade 3) post-operatively.As a result, the patient underwent explantation on (b)(6) 2024.This report is for the right side device.

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.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).

Manufacturer Narrative

Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the smooth mod high xtra, 400cc 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.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
• Type of Device: 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: 18988091
• MDR Text Key: 338728387
• Report Number: 1645337-2024-03737
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 10081317027857
• UDI-Public: 10081317027857
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: SMHX400
• Device Lot Number: 9880770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female