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

Model Number	THPX470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/19/2020
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: ptosis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with two 470cc mentor memorygel xtra breast implant prostheses and experienced postoperative right-sided grade iv capsular contracture and bilateral ptosis postoperatively.During the consultation held on (b)(6) 2020, the patient's physician stated that the right breast appeared to be higher than the left side, and the patient experienced right double bubble deformity and device migration due to the capsular contracture.The diagnosis was confirmed via physical examination.As a result, the patient underwent bilateral mastopexy and unilateral removal and replacement with a 470cc mentor memorygel xtra breast implant (right catalog #: thpx470, right serial #: (b)(4)) for the right side on (b)(6) 2020.This report is for the left-sided prosthesis.

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLAN
• 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: 11389107
• Report Number: 1645337-2021-01204
• Device Sequence Number: 16964945
• Product Code: FTR
• UDI-Device Identifier: 00081317025733
• UDI-Public: 00081317025733
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: 09/19/2023
• Device Model Number: THPX470
• Device Catalogue Number: THPX470
• Device Lot Number: 7625060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/26/2021
• 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: 36 YR