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

Model Number	3544325
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/16/2021
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: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast augmentation primary with mentor memorygel breast implants 350cc (r) and 325cc (l) and reported rupture on the right side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent removal and replacement with similar devices on (b)(6) 2022.Two devices were received damaged.As a result, both devices will be conservatively reported for bilateral rupture in the absence of additional information.This report is for the left breast prosthesis.See manufacturer report number 1645337-2022-02408 for contralateral device.
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the gel siltex 325cc breast implant was found to have an area of delamination at the union between the patch and shell, causing gel leakage.Although potential causes of patch delamination are unknown, stresses and forces on the implant in-vivo or exposure to betadine at insertion could result in delamination and ruptures.Per the current product insert data sheet (pids), rupture is a known complication associated with these devices and can occur at any time during or after implantation.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 13981034
• Report Number: 1645337-2022-03661
• Device Sequence Number: 6031650
• Product Code: FTR
• UDI-Device Identifier: 00081317001058
• UDI-Public: 00081317001058
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2022
• 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: 04/26/2009
• Device Model Number: 3544325
• Device Catalogue Number: 3544325
• Device Lot Number: 5530745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2004
• 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: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White