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

Model Number	3341357
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	10/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: surgery perform to treat migrating implants.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient who underwent a primary breast augmentation procedure with mentor memoryshape breast implant 415cc gel breast prostheses developed capsular contracture (baker grade unknown) in both of her breasts.The patient reported feeling pain and that she could feel her implants flip while doing chores, while bending, and while sleeping on her side.As a result, the patient underwent a surgical intervention to flip and adjust the breast prostheses.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2020, 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.On (b)(6) 2020, mentor received additional information that the explantation date is (b)(6) 2020.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: during visual evaluation of the device, 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.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.As part of our quality process, the manufacturing records of lot 6865748 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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 24-jun-2020, mentor received additional information about the event.The patient¿s capsular contracture is baker grade ii in both of her breasts.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.In addition, mentor received additional information that the patient had her removed breast prostheses replaced with mentor memorygel breast implant 490cc gel breast prostheses.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: 9541192
• Report Number: 1645337-2020-00130
• Device Sequence Number: 11348092
• Product Code: FTR
• UDI-Device Identifier: 00081317004967
• UDI-Public: 00081317004967
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2019
• Device Model Number: 3341357
• Device Catalogue Number: 3341357
• Device Lot Number: 6865748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 02/19/2020; 04/22/2020; 06/24/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/27/2020; 03/10/2020; 04/23/2020; 06/29/2020
• 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: 31 YR