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

Model Number	3341309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	03/24/2021
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.Explantation month, day, and year: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient who underwent a breast augmentation revision procedure with mentor memoryshape breast implant 445cc gel breast prostheses developed baker grade iii capsular contracture in both of her breasts post-implantation.Bilateral capsular contracture was confirmed by a healthcare professional.As a result, the patient is scheduled to undergo bilateral explantation on (b)(6) 2021.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On 01-oct-2021, the mentor failure analysis lab received the device for evaluation.Mentor also received additional information stating that the patient had her removed breast prostheses replaced with mentor smooth round moderate plus profile 350cc gel breast prostheses following explant surgery.On 13-oct-2021, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the patient developed capsular contracture with a mentor breast implant.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.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 implant capsules and effusion to pathology for examination.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 MEMORYSHAPE 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: 12368776
• Report Number: 1645337-2021-09571
• Device Sequence Number: 1206492
• Product Code: FTR
• UDI-Device Identifier: 00081317005094
• UDI-Public: 00081317005094
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/17/2021

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: 04/07/2021
• Device Model Number: 3341309
• Device Catalogue Number: 3341309
• Device Lot Number: 7313812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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: 56 YR