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

Model Number	SHPX260
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a african american female who underwent a breast reconstruction revision with a mentor memorygel, 560cc on the left, and 260cc on the right side silicone breast implant experienced bilateral silent rupture postoperative.As a result, patient underwent bilateral replacements as follow: l) cat#:9583050, sn#: (b)(4), r) cat#:7505373; sn: (b)(4) on (b)(6) 2022.This report relates to the right prosthesis.
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: silent 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
Based on postmarket study data, the alert/awareness dates for this event have been updated.As a result, the initial report is retroactively considered late.Additional information received on jul 2, 2022 indicated that the patient experienced left-sided anisomastia, and right-sided capsular contracture unknown grade postoperatively.During the explant surgery both devices were found to be intact.Manufacturer¿s reference number: (b)(4) the initial report section b5 mistakenly reported incorrect replacements' cat#s.Correction: replacements as follow: r) cat#: shpx260; sn#: (b)(6), l) cat#: shpx560, sn#: (b)(6).
Additional Manufacturer Narrative
On march 22, 2023, per clinician re-review of the event, pec - adverse event was removed, and added pec - rupture symptomatic (post-implant) was added.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per additional information received on august 25, 2023, the patient also experienced left side capsular contracture grade iv and right sided grade iii.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on february 08, 2024 indicated that possible bilateral rupture mri (b)(6) 2022, was clarified during surgery doe (b)(6) 2022, both devices were found intact.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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15213705
• Report Number: 1645337-2022-09374
• Device Sequence Number: 2199987
• Product Code: FTR
• UDI-Device Identifier: 00081317025221
• UDI-Public: 00081317025221
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 08/17/2022
• Device Model Number: SHPX260
• Device Catalogue Number: SHPX260
• Device Lot Number: 7502195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 07/02/2022; 03/22/2023; 08/25/2023; 02/08/2024
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/18/2022; 03/24/2023; 08/31/2023; 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2017
• 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 Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American