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

Model Number	3542007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/04/2019
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: left capsular contracture; baker grade iii.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent revision breast augmentation with a 200cc mentor memorygel breast implant on both sides and experienced bilateral capsular contracture; baker grade iii postoperatively.As a result, the devices were explanted on (b)(6) 2019.This report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On (b)(6) 2021, the mentor failure analysis lab received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.The paperwork received with the devices indicated that the surgery date was (b)(6) 2019.Hence, field d6b has been updated from (b)(6) 2019 to (b)(6) 2019 on this form.This supplemental report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the gel siltex mod-rnd 200cc 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.This supplemental report is for the patient¿s left-sided device.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: 11107593
• Report Number: 1645337-2020-16430
• Device Sequence Number: 17042973
• Product Code: FTR
• UDI-Device Identifier: 00081317000631
• UDI-Public: 00081317000631
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2020

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: 02/29/2016
• Device Model Number: 3542007
• Device Catalogue Number: 3542007
• Device Lot Number: 6445390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/26/2021; 03/08/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/08/2021; 03/09/2021
• 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