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

Catalog Number	SMPX685
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number ip-00514916.This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.Device evaluation summary: according to the information reported, the patient experienced a rupture in the breast implant.During evaluation of the sample, it appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No additional anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.The reported complaint was not confirmed.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.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.Reason for device explant and/or reoperation: suspected rupture of breast prosthesis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This report contains supplemental information for mentor psr reference number ip-00514916.It was reported that a (b)(6) female patient underwent a breast reconstruction revision procedure with mentor memorygel breast implant 685cc gel breast prostheses that bilaterally ruptured after implantation.The patient first noticed the right prosthesis had ruptured, then later noticed the left prosthesis had ruptured.As a result, the patient underwent bilateral explantation on (b)(6) 2019.This medwatch report is for the patient¿s left breast prosthesis.

• Brand Name: MENTOR MEMORYGEL 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: 9118691
• Report Number: 3006942524-2019-00543
• Device Sequence Number: 1776485
• Product Code: FTR
• UDI-Device Identifier: 00081317025160
• UDI-Public: 00081317025160
• Combination Product (Y/N): N
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 09/10/2022
• Device Catalogue Number: SMPX685
• Device Lot Number: 7505714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 09/25/2019
• 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: 54 YR