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

Model Number	3541257
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Breast Mass (2439); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: according to the information received, the patient developed ptosis in the breast.During the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.Reason for device explant and/or reoperation: left breast prosthesis rupture, bilateral breast ptosis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a primary breast augmentation procedure with a mentor memorygel breast implant 300cc gel breast prosthesis (left device) and a mentor memorygel breast implant 125cc gel breast prosthesis (right device) when the left breast prosthesis ruptured after implantation.Rupture of the patient¿s left breast prosthesis was diagnosed by a healthcare professional.In addition, the patient developed bilateral breast ptosis.As a result, the patient underwent bilateral explantation and replacement with a mentor memorygel breast implant 300cc gel breast prosthesis and a mentor memorygel breast implant 125cc gel breast prosthesis on (b)(6) 2020.The left breast prosthesis was discarded after explantation.This medwatch report is for the patient¿s right breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor completed a second investigation on the suspect medical device to address the patient¿s right breast mass.Device evaluation summary: according to the information received, the patient developed ptosis and a breast mass.During the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, mentor received additional information about the event.The patient developed a palpable mass in her right breast.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: 10330182
• Report Number: 1645337-2020-09202
• Device Sequence Number: 2526466
• Product Code: FTR
• UDI-Device Identifier: 00081317000600
• UDI-Public: 00081317000600
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2020

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: 11/30/2007
• Device Model Number: 3541257
• Device Catalogue Number: 3541257
• Device Lot Number: 254091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/28/2020; 08/25/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/18/2020; 08/26/2020
• 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: 40 YR