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

Model Number	3541108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation primary with a mentor memoryshape breast implant 215cc on the right side and with mentor memoryshape breast implant 245cc on the left side and suffered from ¿ pain, firmness and multiple symptoms on the right side.¿ the patient experienced seroma and capsular contracture baker grade ii on the right side confirmed on a mammogram on (b)(6) 2020.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On 4/5/2020, a manufacturing record evaluation was performed for the finished device 7465185 number, and no non-conformances were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 27, 2023, mentor received an updated baker grade (4) and a new date of explant ((b)(6) 2023).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 27, 2023, 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 mentor memoryshape¿ mm 215cc breast implant.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.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.A second product was received (lot-6831764).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.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, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 9918384
• Report Number: 1645337-2020-05248
• Device Sequence Number: 11465210
• Product Code: FTR
• UDI-Device Identifier: 00081317005438
• UDI-Public: 00081317005438
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 03/12/2020

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: 05/02/2022
• Device Model Number: 3541108
• Device Catalogue Number: 3541108
• Device Lot Number: 7465185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/05/2020; 07/27/2023; 11/27/2023
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/24/2020; 08/16/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2017
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Female