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

Model Number	3546501
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Granuloma (1876); Deformity/ Disfigurement (2360)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
This report contains supplemental information for mentor psr reference number (b)(4).It was reported that a black or african american patient underwent primary breast augmentation with 650cc mentor memorygel breast implant and experienced breast implant rupture on her left side postoperatively.On october 27, 2022, mentor became aware taht the patient underwent bilateral explantation and replacement with catalog number 3505504bc; serial number (b)(4) on the left side, and with catalog 3505504bc; serial number (b)(4) on the right side on (b)(6) 2022.
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number (b)(4).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.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: left rupture.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 2, 2022, mentor became aware that the 39-year-old patient experienced breast implant rupture on the left side complicated by granuloma formation in the left axilla region and confirmed by mri.It was also reported that the patient developed capsular contracture bg-iii in both breasts.It was also reported that the patient developed hypertrophic scar of the right and left breasts.Corresponding additional codes have been added under section h on this form.Reason for device explant and/or reoperation: left rupture, granuloma, and capsular contracture bg-iii this supplemental medwatch report is for the patient¿s left-sided device.Right side complication is being reported separately.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 15715305
• Report Number: 1645337-2022-13229
• Device Sequence Number: 6656989
• Product Code: FTR
• UDI-Device Identifier: 00081317003922
• UDI-Public: 00081317003922
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 01/13/2017
• Device Model Number: 3546501
• Device Catalogue Number: 3546501
• Device Lot Number: 6533744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American