MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE LM+ 370CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/30/2020
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 (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: right capsular contracture; baker grade iii.Date of explant: (b)(6) 2020.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This event is associated with the glow study# (b)(4).It was reported that a (b)(6) year-old caucasian female patient underwent primary breast augmentation with a 330cc mentor memoryshape breast implant on the left side, and with 370cc mentor memoryshape breast implant on right side on (b)(6) 2015, and experienced bilateral capsular contracture; baker grade iii postoperatively.As a result, the patient will undergo bilateral explantation on (b)(6) 2020.This report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On december 30, 2020, mentor became aware that the patient underwent replacement with 475cc mentor gel implant on the right side, and with 425cc mentor gel implant on the left side on (b)(6) 2020.On january 5, 2021, the mentor failure analysis lab received the device for evaluation.On january 8, 2021, device evaluation was completed.Device evaluation summary: during visual evaluation no apparent damage or visual anomalies were observed on the returned device.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.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.This supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE LM+ 370CC
• 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: 10931087
• Report Number: 1645337-2020-15281
• Device Sequence Number: 3234576
• Product Code: FTR
• UDI-Device Identifier: 00081317004950
• UDI-Public: 00081317004950
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/18/2020

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: 01/14/2020
• Device Model Number: 3341307
• Device Catalogue Number: 3341307
• Device Lot Number: 6890299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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: 53 YR