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

Catalog Number	3501504BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: capsular contracture on 12/5/201, the product investigation was completed.Device investigation summary: upon receipt by mentor, the gel contained in the device appears cloudy.No foreign material was observed within the device.Gel was observed on the shell surface.Upon visual examination, the device presented no anomalies.No other anomalies were discovered.A root cause failure analysis will not be conducted since the investigation could not confirm that an actual failure of the device to conform to expected performance had occurred.Capsular contracture is the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Product evaluation concluded the reported complaint of 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.Manufacturer¿s reference number: (b)(4).This report contains supplemental information for mentor psr reference number (b)(4).Mentor became aware that psr submission (b)(4) was a duplicate of this complaint file.All further supplemental information with be submitted under this complaint file.
Event or Problem Description
It was reported that a (b)(6)-year old caucasian female patient who underwent primary breast augmentation with two 150cc mentor memorygel breast implants, suffered bilateral breast capsular contracture; baker grade iv, post-operatively.As a result, the patient underwent bilateral removal and replacement on (b)(6) 2018 with the following devices: (right) 300cc mentor memorygel breast implant catalog: 3503004bc, lot: 7583723, sn: (b)(4) and (left) 300cc mentor memorygel breast implant catalog: 3503004bc, lot: 7485135, sn: (b)(4).This medwatch form is for the right breast prosthesis.This report contains supplemental information for mentor psr reference number (b)(4).Mentor became aware that psr submission (b)(4) was a duplicate of this complaint file.All further supplemental information with be submitted under this complaint file.

• 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
• MDR Report Key: 9495020
• Report Number: 1645337-2019-25918
• Device Sequence Number: 2105212
• Product Code: FTR
• UDI-Device Identifier: 00081317000402
• UDI-Public: 00081317000402
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: 04/21/2022
• Device Catalogue Number: 3501504BC
• Device Lot Number: 7460977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR