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

Catalog Number	SMPB290
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: right device migration.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 58-year-old female patient underwent revision breast augmentation with 290cc mentor memorygel boost breast implant on both sides and experienced capsular contracture; baker grade iii on her left side postoperatively; diagnosed in the office.The patient has consulted with the healthcare professional.On (b)(6) 2023, mentor became aware that the date of replacement surgery with non-mentor devices is (b)(6) 2023.On (b)(6) 2023, the mentor failure analysis lab received devices for evaluation.On (b)(6) 2023, mentor became aware that the patient also experienced right side device malposition in addition to left side capsular contracture; baker grade iii.This medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On november 22, 2023, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the smo ro mod pro boost gel 290cc breast implant.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BOOST 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: 18172158
• Report Number: 1645337-2023-13743
• Device Sequence Number: 15356030
• Product Code: FTR
• UDI-Device Identifier: 00081317026853
• UDI-Public: 00081317026853
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: SMPB290
• Device Lot Number: 9769571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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: 58 YR
• Patient Sex: Female