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

Catalog Number	3507445MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/16/2024
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: breast prosthesis rupture.D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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 patient underwent a breast augmentation revision procedure with an unspecified mentor smooth gel breast prosthesis that ruptured post implantation.Rupture of the patient¿s right breast prosthesis was diagnosed via mammogram and ultrasound.As a result, the patient underwent bilateral explantation and replacement with mentor memorygel breast implant 475cc gel breast prostheses on (b)(6) 2024.
Additional Manufacturer Narrative
On 16-sep-2024, mentor received additional information about the event.Mri results diagnosed right breast prosthesis ruptured.Additionally, the mri indicated an area of palpable concern in the left breast.It was reported to be a probably benign mass.This medwatch report is for the patient¿s right breast prosthesis.Refer to manufacturer report number 1645337-2024-11660 for the report for the patient¿s left breast prosthesis.On 17-sep-2024, mentor received additional information about the event.This suspect medical device is a mentor memorygel breast implant 445cc gel breast prosthesis, catalog #3507445mc, pma #p030053.Two lot numbers were reported for the patient¿s two breast prostheses: 6521102 and 6525530.The lot number was populated in block d as 6521102.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.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 09-oct-2024, the mentor failure analysis lab received the device for evaluation.On 11-oct-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a rupture in the breast implant.The product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to have an area of shell abrasion on the posterior view.In addition, a tear was noted within the shell abrasion measuring approximately 7.4 cm.The evaluation determined that the possible cause of the rupture was consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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: 20207761
• Report Number: 1645337-2024-10664
• Device Sequence Number: 7769869
• Product Code: FTR
• UDI-Device Identifier: 00081317004219
• UDI-Public: 00081317004219
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 3507445MC
• Device Lot Number: 6521102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 10/09/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/04/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2011
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American