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

Model Number	SMPX560
Medical Device Problem Codes	Material Discolored (1170); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: capsular contracture.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).
Event or Problem Description
It was reported that a 66-year-old caucasian female patient who underwent an unspecified breast surgery with mentor memorygel xtra breast implant 560cc gel breast prostheses developed capsular contracture (baker grade unknown) in both of her breasts post implantation.As a result, the patient underwent unilateral explantation of the left breast prosthesis on (b)(6) 2022 and it was replaced with an unspecified breast prosthesis.The surgeon observed that the explanted left breast prosthesis appeared abnormal and that the gel inside it had a white discoloration.At the time of this report, mentor has received no information regarding explantation or an expected explantation date for the patient¿s right breast prosthesis.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On 31-oct-2022, mentor became aware that the side of implant was switched when the complaint was reported.It was previously reported that this report is for the patient¿s left breast prosthesis.Lot # 7643276, serial #(b)(6) actually pertains to the patient¿s right breast prosthesis.As a result, the following updates were made: - block b1 is product problem no longer applies to this report - block b2 is required intervention no longer applies to this report (right device was not explanted) - h6 medical device problem codes a0203 & a0407 no longer apply to this report.Reason for device explant and/or reoperation: n/a (device was not explanted) 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: 15683046
• Report Number: 1645337-2022-13015
• Device Sequence Number: 20426156
• Product Code: FTR
• UDI-Device Identifier: 00081317025122
• UDI-Public: 00081317025122
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 10/18/2023
• Device Model Number: SMPX560
• Device Catalogue Number: SMPX560
• Device Lot Number: 7643276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2018
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White