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

Model Number	3542007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent a breast augmentation procedure with a mentor memorygel breast implant 275cc gel breast prosthesis (left device) and a mentor memorygel breast implant 200cc gel breast prosthesis (right device) developed an unspecified deformity bilaterally post implantation.As a result, the patient is scheduled to undergo bilateral explantation and replacement with unspecified mentor gel breast prostheses on (b)(6) 2022.This medwatch report is for the patient¿s right breast prosthesis.
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: breast deformity.Explantation month, day, and year: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 19-apr-2022, the mentor failure analysis lab received the device for evaluation.On 03-may-2022, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient developed an unspecified deformity bilaterally.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry 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 to approved specifications.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 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13778913
• Report Number: 1645337-2022-02842
• Device Sequence Number: 3905946
• Product Code: FTR
• UDI-Device Identifier: 00081317000631
• UDI-Public: 00081317000631
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2010
• Device Model Number: 3542007
• Device Catalogue Number: 3542007
• Device Lot Number: 5589603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2005
• 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: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White