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

Model Number	3341454
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/04/2020
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: infection.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient, who's undergone breast reconstruction as part of a clinical study with two 755cc mentor memoryshape breast implants on (b)(6) 2020, suffered bilateral breast infections, post-procedure.The onset of the right infection was on (b)(6) 2020 and the left side infection was on (b)(6) 2020.As a result, the patient underwent implant explanation of the right device on (b)(6) 2020 and replacement with a 755cc mentor memoryshape breast implant (catalog: 3341454 lot: 9409188 sn: (b)(4)) on (b)(6) 2020.The left side implant was removed on (b)(6) 2020 and replaced with a 755cc mentor memoryshape breast implant (catalog: 3341454 lot: 9441651 sn: (b)(4)) on (b)(6) 2020.This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On december 28, 2021, mentor became aware that the suspect medical device was implanted for primary breast reconstruction.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 31, 2023, mentor received additional information indicating that the correct date of event for the left breast was on (b)(6) 2020.

• 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: 11721502
• Report Number: 1645337-2021-04499
• Device Sequence Number: 11703543
• Product Code: FTR
• UDI-Device Identifier: 00081317024279
• UDI-Public: 00081317024279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/04/2021

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: 03/29/2025
• Device Model Number: 3341454
• Device Catalogue Number: 3341454
• Device Lot Number: 9441651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 03/31/2023
• Initial Report FDA Received Date: 04/24/2021
• Supplement Report FDA Received Date: 01/20/2022; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2020
• 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 Ethnicity: Non Hispanic
• Patient Race: White