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

Catalog Number	3341202
Medical Device Problem Codes	Material Rupture (1546); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360); Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2017
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.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.Reason for device explant and/or reoperation: rupture, capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a breast reconstruction with mentor memoryshape breast implants and experienced bilateral capsular contracture baker grade iv along with rupture on the left side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent a capsulectomy on the right side on (b)(6) 2017.At the time of this report, mentor has received no information regarding explantation or an expected explantation date for the right side.The left breast prosthesis was removed on (b)(6) 2022.This report is for the left breast prosthesis.See manufacturer report number 1645337-2021-06948 for contralateral side.
Additional Manufacturer Narrative
On oct 12, 2023, additional information was received indicating the adverse event reported for the contralateral (left) side was reported in error.There were no issues experienced by the patient on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On oct 29, 2024, additional information was received indicating the patient experienced rupture on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On dec 10, 2024, additional information was received indicating the patient experienced capsular contracture baker grade iv on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jul 1, 2025, additional information was received indicating the patient also experienced an infection on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jan 8, 2026, additional information was received indicating the capsular contracture baker grade is grade iii bilaterally.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On feb 27, 2026, additional information was received indicating the date of event was (b)(6) , 2017.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On sep 18, 2026, additional information was received indicating the patient also experienced device migration on the right side.Manufacturer¿s reference number: (b)(4).

• 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: 17879203
• Report Number: 1645337-2023-11847
• Device Sequence Number: 20697173
• Product Code: FTR
• UDI-Device Identifier: 00081317005209
• UDI-Public: 00081317005209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: 03/23/2020
• Device Catalogue Number: 3341202
• Device Lot Number: 6915643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 10/29/2024; 12/10/2024; 07/01/2025; 01/08/2026; 02/27/2026
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/01/2023; 11/27/2024; 01/02/2025; 07/25/2025; 01/29/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2015
• 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 Sex: Female
• Patient Weight: 160 LB
• Patient Race: White