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

Model Number	3341102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Wrinkling (2613)
Date of Event	01/02/2019
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: asymmetry, wrinkling, anxiety about textured implants.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient who underwent a primary breast reconstruction with a mentor memoryshape breast implant 330cc gel breast prosthesis (left device) and a mentor memoryshape breast implant 345cc gel breast prosthesis (right device) developed asymmetry of the breasts post implantation.As a result, the patient underwent unilateral explantation of the right breast prosthesis and it was replaced with a mentor memoryshape breast implant 300cc gel breast prosthesis gel breast prosthesis on (b)(6) 2018.It was later reported that the patient developed breast asymmetry again.Additionally, the patient developed wrinkling on both breasts.The patient also developed anxiety about her textured breast implants.As a result, the patient underwent bilateral explantation and replacement with a mentor memorygel xtra breast implant 380cc gel breast prosthesis and a mentor memorygel xtra breast implant 355cc gel breast prosthesis on (b)(6) 2019.This medwatch report is for the patient¿s second right breast prosthesis that was implanted on (b)(6) 2018.Refer to manufacturer report number 1645337-2022-12582 for the patient¿s right breast prosthesis that was implanted on (b)(6) 2018 and manufacturer report number 1645337-2022-12583 for the patient¿s left breast prosthesis.

• 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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 16236957
• Report Number: 1645337-2023-00763
• Device Sequence Number: 6474814
• Product Code: FTR
• UDI-Device Identifier: 00081317005186
• UDI-Public: 00081317005186
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 08/20/2021
• Device Model Number: 3341102
• Device Catalogue Number: 3341102
• Device Lot Number: 7366168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White