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

Model Number	SMPX160
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/07/2021
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 baker grade iv.Explantation date: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent a primary breast augmentation with 160cc smooth mentor memorygel breast implant experienced left-sided grade iv capsular contracture postoperatively.Capsular contracture was confirmed by a physician.As a result, the patient is scheduled to undergo explantation on (b)(6) 2021.
Additional Manufacturer Narrative
On (b)(6) 2021, additional information was received indicating the patient underwent explantation on (b)(6) 2021.On (b)(6) 2021, additional information was received indicating the device was removed and reinserted back into the patient.This is an off-label use of the device per the ifu.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
See h11 for correction details.Manufacturer¿s reference number: (b)(4) on oct 8 2021, it was noticed the following information was incorrect in the previous report: a date of explantation was provided.Since the device was reinserted back into the patient, the date of expantation has been removed.

• 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: 12119282
• Report Number: 1645337-2021-07514
• Device Sequence Number: 17245962
• Product Code: FTR
• UDI-Device Identifier: 00081317024972
• UDI-Public: 00081317024972
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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
• Report Date (Section B): 06/07/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2024
• Device Model Number: SMPX160
• Device Catalogue Number: SMPX160
• Device Lot Number: 9359136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 10/08/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 09/23/2021; 10/08/2021
• 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: Required Intervention
• Patient Age: 70 YR