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

Model Number	3545557MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number ip-ip-00377884.This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.On (b)(6) 2019, mentor became aware that patient also suffered generalized illness.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.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 daily routines such as vigorous exercise, athletics, routine manual massage and intimate physical contact, mechanical damage prior to or during surgery, closed capsulotomy, capsular contracture and origins which are simply unknown.Excessive postoperative accumulation and/or transient reaccumulation of fluid around an implant most likely occur soon after surgery; however, it can occur at any time.Symptoms from seroma may include swelling, pain, and bruising.While the body absorbs small hematomas and seromas, some will require surgery.Seromas presenting after the immediate post-operative period may require additional work-up by the surgeon.Seroma is a known complication associated with this surgery and is referenced in our current product insert data sheet.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: bilateral rupture, seroma, generalized illness.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This report contains supplemental information for mentor psr reference number ip-ip-00377884.It was reported that a (b)(6) caucasian female patient underwent revision breast augmentation revision with 555cc mentor memorygel breast implants on 12/11/2014 developed bilateral rupture that was observed on (b)(6) 2018.Seroma and generalized illness were also reported.The patient underwent bilateral removal and replacement with catalog number 3545557mc; serial number (b)(4) on the right side and with catalog number 3545557mc; serial number (b)(4) on the left side on (b)(6) 2018.This report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
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 supplemental report is for the patient¿s left-sided device.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: 9098079
• Report Number: 1645337-2019-19763
• Device Sequence Number: 2568386
• Product Code: FTR
• UDI-Device Identifier: 00081317004509
• UDI-Public: 00081317004509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 04/30/2016
• Device Model Number: 3545557MC
• Device Catalogue Number: 3545557MC
• Device Lot Number: 6462522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 05/07/2020
• 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: 62 YR