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

Model Number	THPX425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/05/2023
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.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: capsular contracture grade iii.Manufacturer¿s reference number: pc-(b)(4).
Event or Problem Description
It was reported that a 53-year-old female who underwent a breast augmentation revision with a mentor memorygel xtra, 405cc on the right and 425cc on the left side, silicone prosthesis experienced bilateral capsular contracture grade iii post procedure.The issue was diagnosed through patient symptoms.As a result, patient scheduled for bilateral; removal on.This report relates to the left side.
Additional Manufacturer Narrative
Per additional information received on july 26, 2023 date of removal updated to (b)(6) 2023.Please see patient previous event in manufacturer report number:1645337-2023-08529.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Suspect device received on aug 22, 2023.Device evaluation completed on aug 23 , 2023: investigation summary: according to the information reported, the patient developed capsular contracture.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 425cc returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.It should be noted that 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, capa activity was not required.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 WORLDWIDE LLC; 31 technology drive; suite 200; irvine TX 92618
• 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: 17321255
• Report Number: 3006942524-2023-00012
• Device Sequence Number: 12399146
• Product Code: FTR
• UDI-Device Identifier: 00081317025719
• UDI-Public: 00081317025719
• 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: 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,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: 05/06/2026
• Device Model Number: THPX425
• Device Catalogue Number: THPX425
• Device Lot Number: 9559911
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 08/22/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/09/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2021
• 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: 53 YR
• Patient Sex: Female