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

Model Number	3507640MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Local Reaction (2035)
Date of Event	08/20/2020
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: capsular contracture, local reaction.Date of explantation: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) african american female patient underwent a revision breast augmentation with two 640cc mentor memorygel breast implant prostheses and experienced bilateral grade iv capsular contracture and right-sided location reaction postoperatively.The patient had a five-weeks post-op follow-up on 20-aug-2020, and the patient stated she experienced right-sided breast tenderness and swollen breast.At another post-op follow-up on 15-oct-2020, the diagnosis of bilateral capsular contracture was confirmed via physical examination.As a result, the patient is scheduled to undergo removal and replacement with 555cc mentor memorygel breast implant prostheses (catalog #: 3507555mc) on (b)(6) 2021.This report is for the right-sided prosthesis.
Additional Manufacturer Narrative
On 7-oct-2021, mentor received additional information regarding the date of explantation and suspected medical device.Initially, the date of explantation was reported as (b)(6) 2021.However, additional information revealed that the actual date of explantation was (b)(6) 2021.The relevant field has been updated.The suspected medical device was returned for evaluation.On 11-oct-2021, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).

• 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: 11174232
• Report Number: 1645337-2021-00428
• Device Sequence Number: 3726955
• Product Code: FTR
• UDI-Device Identifier: 00081317004271
• UDI-Public: 00081317004271
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 12/16/2023
• Device Model Number: 3507640MC
• Device Catalogue Number: 3507640MC
• Device Lot Number: 7669646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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: 56 YR