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

Model Number	3542357MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/04/2020
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: capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient, who's undergone breast augmentation revision with two 235cc mentor memorygel breast implants, suffered bilateral breast capsular contractures (baker grade iii), post-procedure.The capsular contractures were diagnosed via wave examination.As a result, the patient underwent bilateral removal and then bilateral replacement with two unspecified implants on (b)(6) 2020.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On february 11, 2021, the mentor failure analysis lab received the device for evaluation.Mentor also became aware that the correct date of explantation was november 11, 2019.On february 17, 2021, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the sx mod classic gel, 235cc 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 11092261
• Report Number: 1645337-2020-16479
• Device Sequence Number: 630752
• Product Code: FTR
• UDI-Device Identifier: 00081317004363
• UDI-Public: 00081317004363
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 01/20/2021
• Device Model Number: 3542357MC
• Device Catalogue Number: 3542357MC
• Device Lot Number: 7283936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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