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

Catalog Number	SHPX755
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
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: as of now there is no information regarding the explant or reoperation.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 54-year-old caucasian female patient underwent revision breast augmentation with 755cc mentor memorygel xtra breast implant and experienced breast implant rupture, and capsular contracture; baker grade unknown on her right side postoperatively.The patient has consulted with the healthcare professional.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On march 14, 2024, mentor became aware that this mentor manufacturer's report number is a duplicate of mentor manufacturer's report number 1645337-2021-09717.Hence, any additional information will be reported under the manufacturer's report number 1645337-2021-09717.Coding have been updated under section h on this form accordingly.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 26, 2024, mentor became aware that the right side device is still implanted, bilateral mastopexy was performed with serial number (b)(6) on the left side, and number (b)(6) on the right side.While right device was still implanted, left side implant was replaced with a mentor smx-605 silicone on (b)(6) 2022.Coding have been updated accordingly under section h on this form.This supplemental medwatch report is for the patient¿s right-sided device.Left side mastopexy is being reported separately.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 1, 2024, mentor became aware of the following and corresponding fields have been updated on this form: date of event was (b)(6) 2022; field b3 has been updated.Patient experienced grade iv capsular contracture on the right side.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 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: 18767525
• Report Number: 1645337-2024-01987
• Device Sequence Number: 18049221
• Product Code: FTR
• UDI-Device Identifier: 00081317025368
• UDI-Public: 00081317025368
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: 10/29/2025
• Device Catalogue Number: SHPX755
• Device Lot Number: 9512460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 03/14/2024; 03/26/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/12/2024; 03/23/2024; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2020
• 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: Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White