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

Model Number	SMPX605
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/30/2021
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 (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: na.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year old caucasian female patient, who's undergone breast augmentation revision with two 605cc mentor memorygel breast implants on (b)(6) 2021, immediately felt dissatisfied with the implants they received, post-procedure.The patient wanted high profile implants but expressed that the implants they received looked smaller than the one removed and replaced.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On may 24, 2021, mentor received additional information indicating that the patient is now also experiencing a left breast that looks smaller and deflated.Manufacturer¿s reference number: (b)(4).This medwatch form is for the left breast prosthesis.

• 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
• MDR Report Key: 11708204
• Report Number: 1645337-2021-04369
• Device Sequence Number: 16928397
• Product Code: FTR
• UDI-Device Identifier: 00081317025139
• UDI-Public: 00081317025139
• Combination Product (Y/N): N
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 09/17/2025
• Device Model Number: SMPX605
• Device Catalogue Number: SMPX605
• Device Lot Number: 9501727
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR