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

Model Number	3541708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Wrinkling (2613); No Code Available (3191)
Date of Event	01/01/2019
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 (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: n/a.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 reconstruction primary with a mentor memoryshape breast implant 775cc and suffered from a bilateral capsular contracture baker grade baker grade iv on the right and baker grade iii on the left breast implant and rupture on the left breast implant.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch is for the right breast implant.
Additional Manufacturer Narrative
On 10/16/2020, it was reported to mentor that there was no capsular contracture on the right side.The date of removal was on (b)(6) 2020.Reason for device explant and / or reoperation: anisomastia.H6 patient code 3191: medical device removal.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, it was reported to mentor that the patient experienced bilateral breast deformity.The replacement devices were non-mentor brand allergan devices.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 11/9/2020, it was reported to mentor that the complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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: 10480864
• Report Number: 1645337-2020-10927
• Device Sequence Number: 14110111
• Product Code: FTR
• UDI-Device Identifier: 00081317005537
• UDI-Public: 00081317005537
• 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
• Report Date (Section B): 08/11/2020

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: 02/02/2020
• Device Model Number: 3541708
• Device Catalogue Number: 3541708
• Device Lot Number: 6900117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 11/09/2020; 11/09/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/27/2020; 11/09/2020; 11/17/2020
• 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: Other
• Patient Age: 52 YR