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

Catalog Number	3543751
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Post Operative Wound Infection (2446)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 57-year-old caucasian female patient underwent a breast augmentation surgery with implantation of a 375cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured left breast implant using ultrasound imaging and bilateral baker grade ii capsular contracture of the breasts during a consultation with a medical professional.Additionally, silicone has leaked into the left lymph nodes resulting in granuloma formation.As a result, the patient is scheduled for bilateral removal and replacement on (b)(6), 2023.This report is for the right breast prosthesis.Refer to manufacturing report number 1645337-2023-06961 for the contralateral event.
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. reason for device explant and/or reoperation: capsular contracture.Date of explantation: (b)(6), 2023.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On december 01, 2023, mentor was notified that the patient underwent an emergency breast implant removal surgery without replacements due to an infection on (b)(6) 2023.The suspect device was reportedly discarded afterwards.The complaint device has been discarded.  as a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Reason for device explant and/or reoperation: wound infection manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 31, 2023, mentor was provided with an updated explantation date of (b)(6) 2023.Date of explantation: (b)(6) 2023.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 04, 2024, the patient was indicated to have had a left-sided breast infection only.As this report is for the right side, wound infection is no longer applicable.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
• 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: 17634683
• Report Number: 1645337-2023-10019
• Device Sequence Number: 18053596
• Product Code: FTR
• UDI-Device Identifier: 00081317000891
• UDI-Public: 00081317000891
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 3543751
• Device Lot Number: 6834875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 12/01/2023; 01/04/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 11/28/2023; 12/19/2023; 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White