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

Model Number	3341354
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wrinkling (2613); No Code Available (3191)
Date of Event	09/09/2020
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: excess skin.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast reconstruction with two 610cc mentor memoryshape breast implant prostheses (left: revision, right: primary) and experienced bilateral cutaneous contour deformity, left-sided rupture, and right-sided surgical intervention postoperatively.On (b)(6) 2020, the patient had a consultation with a healthcare professional, and the diagnosis was confirmed via physical examination.During the consultation, the patient¿s physician stated that a body scan performed on unspecified date indicated left-sided rupture.In addition, the physician stated that the patient experienced left-sided radiation fibrosis and lipodystrophy, and bilateral excess skin.As a result, the patient underwent a surgical intervention for the excess skin on her right breast and removal and replacement with a 595cc mentor gel breast implant for her left breast on (b)(6) 2020.This report is for the right-sided prosthesis.

• Brand Name: MENTOR MEMORYSHAPE 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: 10796382
• Report Number: 1645337-2020-13847
• Device Sequence Number: 1061298
• Product Code: FTR
• UDI-Device Identifier: 00081317024255
• UDI-Public: 00081317024255
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 04/17/2023
• Device Model Number: 3341354
• Device Catalogue Number: 3341354
• Device Lot Number: 7564716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/05/2020
• 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: 66 YR