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

Model Number	3341404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Impaired Healing (2378); Wrinkling (2613)
Date of Event	05/21/2021
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.Reason for device explant and/or reoperation: breast asymmetry.Manufacturer¿s reference number: pc-(b)(4).
Event or Problem Description
It was reported that a caucasian female patient who underwent a breast augmentation revision procedure with a mentor memorygel breast implant 450cc gel breast prosthesis (left device) and a mentor memoryshape breast implant 680cc gel breast prosthesis (right device) developed bilateral breast asymmetry.As a result, the patien underwent bilateral explantation and replacement with a mentor memoryshape breast implant 555cc gel breast prosthesis (left device) and a mentor memoryshape breast implant 680cc gel breast prosthesis (right device) on (b)(6) 2020.This medwatch report is for the patient¿s right breast prosthesis.
Additional Manufacturer Narrative
On 04-apr-2023, mentor received additional information about the event.It was reported that the patient suffered from delayed wound healing in her right breast post implantation.This medwatch report is for the patient¿s right breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 30-jun-2023, mentor received additional information about the event.The patient developed breast wrinkling post implantation.It was not specified which breast developed wrinkling (left breast, right breast, or bilateral).The wrinkling will be submitted in this medwatch report.If clarification is received, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
It was previously reported that the patient suffered from delayed wound healing in the right breast.This was attributed to the patient¿s right breast prosthesis that was implanted on (b)(6) 2020.Mentor became aware that the delayed wound healing actually applies to the patient¿s right breast prosthesis that was implanted on (b)(6) 2020.The patient underwent an unspecified surgery on (b)(6) 2020 to address the issue.Refer to manufacturer report number 1645337-2025-08161 for the report related to the device implanted on (b)(6) 2020.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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12081395
• Report Number: 1645337-2021-07292
• Device Sequence Number: 3235728
• Product Code: FTR
• UDI-Device Identifier: 00081317024262
• UDI-Public: 00081317024262
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2024
• Device Model Number: 3341404
• Device Catalogue Number: 3341404
• Device Lot Number: 7747449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 04/04/2023; 06/30/2023; 07/02/2025
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 04/25/2023; 05/30/2024; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2019
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White