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

Catalog Number	3341455
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	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the right side device has not been returned, it has been concluded that the reported complaint of capsular contracture in the patient¿s breast was the result of the body¿s normal physiologic response to the implantation of a foreign object. capsular contracture is a known complication associated with these devices as stated in the ifu. therefore, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation 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: bilateral capsular contracture; baker grade unknown and left side rupture postoperative formation of a fibrous tissue capsule around an implanted device is a normal physiologic response to the implantation of a foreign object.Capsule formation occurs in all patients in varying degrees. capsules range from thin to heavily-thickened.This phenomenon is referred to as capsular contracture. the severity of this condition varies with each individual. capsular contracture can make the breast harder and firmer than desirable which may result in breast asymmetry, discomfort or pain.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) african american, white & native american female patient underwent revision breast reconstruction surgery with a 585cc mentor memoryshape breast implant.The patient reported left side disfigured chest and uncomfortable feeling.On (b)(6) 2016, ultrasound was performed.The physician stated that the implant was completely ruptured.Bilateral capsular contracture; baker grade unknown was also found.As a result, patient underwent bilateral explantation and replacement on (b)(6) 2019 with catalog number shpx700; serial number (b)(4) on the left side and catalog number shpx700; serial number (b)(4) on the right side.This report is for the patient¿s right-sided device.

• 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: 8711578
• Report Number: 1645337-2019-14084
• Device Sequence Number: 11428666
• Product Code: FTR
• UDI-Device Identifier: 00081317005377
• UDI-Public: 00081317005377
• Combination Product (Y/N): N
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 10/08/2019
• Device Catalogue Number: 3341455
• Device Lot Number: 6867570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/19/2019
• 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: 27 YR