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

Model Number	3544650
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/28/2021
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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Date of explantation: (b)(6) 2021 reason for device explant and/or reoperation: breast pain manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with a mentor memorygel breast implant 650cc and experienced capsular contracture baker grade iii on the left side and breast pain on the right side post-operatively, which was confirmed during a physical exam.As a result, the patient is scheduled for removal on (b)(6) 2021.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2021, additional information was received indicating the patient's explantation surgery has been cancelled due to illness.No new surgery date has been scheduled at this time.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jun 24 2021, additional information was received indicating the patient is scheduled for device removal on (b)(6) 2021.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.Reason for device explant and/or reoperation: capsular contracture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jul 28 2021, additional information was received indicating the replacement devices were mentor gel breast implants (serial numbers: (b)(6).On aug 5 2021, additional information was received indicating the patient also experienced device migration on the right side.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: 11385981
• Report Number: 1645337-2021-02082
• Device Sequence Number: 11583900
• Product Code: FTR
• UDI-Device Identifier: 00081317001140
• UDI-Public: 00081317001140
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2022
• Device Model Number: 3544650
• Device Catalogue Number: 3544650
• Device Lot Number: 7433116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 06/24/2021; 07/26/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/27/2021; 07/12/2021; 08/19/2021
• 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: Other; Required Intervention
• Patient Age: 38 YR