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

Model Number	SHPX150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Impaired Healing (2378); Swollen Lymph Nodes/Glands (4432); Breast Discomfort/Pain (4504)
Date of Event	11/22/2022
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: lymphadenopathy/rupture/delayed wound healing/breast pain.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 37-year-old caucasian female who underwent primary breast augmentation with 150cc mentor memorygel xtra breast implants experienced right sided rupture, right sided delayed wound healing, right sided breast pain, right sided lymphadenopathy, bilateral ptosis, and a left sided breast mass post procedure.These issues were demonstrated through magnetic resonance imaging and ultrasound.There is as enlarged right axillary lymph node on the right and 10mm lobulated mass like area of enhancement on the right side.As a result, bilateral capsulotomy, bilateral breast lift, and placement of 200cc mentor smooth round moderate profile saline prostheses was performed on (b)(6) 2023.
Additional Manufacturer Narrative
The investigation of the impacted product was completed by the failure analysis lab on january 26, 2023.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample determined that the breast implant was found to be ruptured and received in three parts.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the anterior aspect measuring approximately 0.3 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: pc-(b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX ; TX
• 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: 16243447
• Report Number: 3006942524-2023-00002
• Device Sequence Number: 6523283
• Product Code: FTR
• UDI-Device Identifier: 00081317025184
• UDI-Public: 00081317025184
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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 Expiration Date: 07/24/2023
• Device Model Number: SHPX150
• Device Catalogue Number: SHPX150
• Device Lot Number: 7608793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White