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

Model Number	3507800BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/20/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation primary with a mentor memorygel breast implant 800cc and suffered from capsular contracture baker grade iv and rupture symptomatic on the left breast implant.As a result, the patient has undergone removal and replacement with non-mentor device on (b)(6) 2020.On (b)(6) 2021, it was reported to mentor that the patient experienced baker grade iv capsular contracture on the right side breast.Possible left side rupture secondary to trauma ¿ chest injury- ((b)(6) 2020 ¿ severe motorcycle accident) , now with malposition and capsular contracture.The replacement devices were allergan brand scx gel implants.The patient had undergone removal of left ruptured silicone implant with some extracapsular silicone extrusion, reconstruction and repair of left pectoralis major muscle on (b)(6) 2020.This medwatch is for the right side.
Additional Manufacturer Narrative
On (b)(6) 2021, a manufacturing record evaluation was performed for the finished device 6002053 number, and no non-conformances were identified.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
• MDR Report Key: 11809343
• Report Number: 1645337-2021-05201
• Device Sequence Number: 17014491
• Product Code: FTR
• UDI-Device Identifier: 00081317000198
• UDI-Public: 00081317000198
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 06/30/2015
• Device Model Number: 3507800BC
• Device Catalogue Number: 3507800BC
• Device Lot Number: 6002053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: 43 YR