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

Catalog Number	THPX470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, during evaluation of the sample it was observed to be intact.No additional anomalies were observed.Based on the facts of the case, is unrelated to the breast implant and related to the patient condition.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.No further investigation will be conducted on this complaint due to external cause.The reported complaint could not be confirmed.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Reason for device explant and/or reoperation: capsular contracture.Concomitant medical products: a mentor memorygel xtra breast implant 470cc , catalog number thpx470, serial number (b)(4), lot number 7543768.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.This report contains supplemental information for mentor psr reference number ip-00511889.This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with a mentor memorygel xtra breast implant 470cc and experienced capsular contracture baker grade iii on the right breast implant.As a result, the patient had undergone removal on (b)(6) 2019.This report contains supplemental information for mentor psr reference number ip-00511889.
Additional Manufacturer Narrative
On 10/8/2019, it was discovered that the awareness date for this complaint was reported incorrectly in the 3500a initial report.The actual awareness date was 5/10/2019.The actual due date for the report was 6/9/2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 9/12/2019, it was erroneously omitted to report that the mentor failure analysis lab has received the device for evaluation on 5/10/2019.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 33 technology drive; irvine 92618
• MDR Report Key: 9007631
• Report Number: 3006942524-2019-00537
• Device Sequence Number: 2308209
• Product Code: FTR
• UDI-Device Identifier: 00081317025733
• UDI-Public: 00081317025733
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: THPX470
• Device Lot Number: 7543768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 10/08/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 09/12/2019; 11/04/2019
• 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: 49 YR