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

Model Number	3546001
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	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: according to the information received, it was reported that the patient developed capsular contracture.During visual inspection of the device it was observed with no apparent damage.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.An investigation of the returned device was performed, and mentor could not uncover a device failure that we could connect to the reported medical symptoms, however complaint information will be included in complaint trending that is reviewed by quality assurance to determine if further action is necessary.Reason for device explant and/or reoperation: capsular contracture baker grade iii.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient who underwent an unspecified breast augmentation with a 600cc textured mentor memorygel breast implant has experienced postoperative right-sided grade iii capsular contracture, confirmed by a physician.As a result, the patient underwent unilateral explantation and replacement with 605cc textured mentor memorygel xtra breast implant, catalog # tmpx605, right serial # (b)(4) on (b)(6) 2020.

• 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: 9753735
• Report Number: 1645337-2020-03071
• Device Sequence Number: 2495975
• Product Code: FTR
• UDI-Device Identifier: 00081317000945
• UDI-Public: 00081317000945
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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: 08/25/2021
• Device Model Number: 3546001
• Device Catalogue Number: 3546001
• Device Lot Number: 7368819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/26/2020
• 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: 57 YR