MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE TM+ 680CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Wrinkling (2613); No Code Available (3191)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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: pain, wrinkling.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent primary breast reconstruction surgery with a mentor memoryshape 680cc silicone prosthesis experienced bilateral pain, left sided wrinkling, right sided capsular contracture, unknown grade, and device migration post procedure.The patient stated that the left side implant popped by the area of nipple, extreme pain on both sides, right implant sits high and hard and not align, it appears like the implant turned and makes it painful, patient can't sleep.Patient stated in 2016 doctor made adjustment for right side, took skin of the sides, and secure it.As a result, patient scheduled for explant on (b)(6) 2021.This report relates to the left prosthesis.

• Brand Name: MENTOR MEMORYSHAPE TM+ 680CC
• 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: 10826216
• Report Number: 1645337-2020-14433
• Device Sequence Number: 16944991
• Product Code: FTR
• UDI-Device Identifier: 00081317005131
• UDI-Public: 00081317005131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 03/23/2020
• Device Model Number: 3341509
• Device Catalogue Number: 3341509
• Device Lot Number: 6915456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/11/2020
• 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: 62 YR