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

Catalog Number	THPX325
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation primary with mentor memorygel xtra breast implants 325cc and experienced bilateral capsular contracture baker grade iii (l) and baker grade ii (r) post-operatively, which was confirmed during a physical exam.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left breast prosthesis.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On sep 4, 2024, additional information was received indicating the explantation surgery is scheduled for (b)(6) 2024.Reason for device explant and/or reoperation: capsular contracture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 18, 2024, additional information was received indicating the patient experienced breast trauma (surfing accident) which may have caused or contributed to the event.The replacement devices were identified as mentor gel breast implants (serial numbers (b)(6) and (b)(6)).H6: health effect - clinical code e2402: chest injury.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On jan 14, 2025, it was noticed the previous report contained errors.The correct serial numbers for the replacement devices are as follows: (b)(4).On jan 21, 2025, the mentor failure analysis lab received the device for evaluation.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the siltex high profile xtra 325cc returned device.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture 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 according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria.Manufacturer¿s reference number: (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 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: 19498934
• Report Number: 1645337-2024-06949
• Device Sequence Number: 20496160
• Product Code: FTR
• UDI-Device Identifier: 00081317025672
• UDI-Public: 00081317025672
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 02/03/2025
• Device Catalogue Number: THPX325
• Device Lot Number: 9416195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 10/18/2024; 01/14/2025
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/23/2024; 11/06/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White