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

Catalog Number	3341402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Cancer (3262); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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: leukemia, generalized illness, and capsular contracture.H6 health effect - clinical code e2402: generalized illness.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 black female patient underwent a breast reconstruction revision with two 620cc mentor memoryshape breast implants and experienced leukemia post-operatively.The patient stated that she believes that implanting the breast prosthesis caused her to have leukemia.Generalized illness symptoms including getting ¿really sick¿, sweats, losing weight, dry mouth, and kidney failure were also reported.In addition, it was mentioned that both patient¿s breasts were hard and had encapsulated.As a result, the patient underwent explantation on (b)(6) 2023 and replaced with a 500cc mentor smooth round moderate plus profile saline breast prostheses.This report is for the right-side device.

• Brand Name: MENTOR MEMORYSHAPE 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: 20428946
• Report Number: 1645337-2024-11945
• Device Sequence Number: 12862565
• Product Code: FTR
• UDI-Device Identifier: 00081317005247
• UDI-Public: (01)00081317005247(17)230909(10)7618554
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2023
• Device Catalogue Number: 3341402
• Device Lot Number: 7618554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2018
• 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; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American