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

Model Number	3341352
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2016
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, generalized illness.Explantation month, day, and year: (b)(6) 2022.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 62-year-old caucasian female patient underwent a primary breast reconstruction procedure with mentor memoryshape breast implant 555cc gel breast prostheses and suffered several unexplained systemic symptoms, including itching, burning sensation, sensitive to touch, bruising, stomach issues, and fatigue.No device issue such as rupture was reported.The root cause of the patient¿s symptoms is unclear.Additionally, the patient developed capsular contracture (baker grade unknown) in both of her breast post implantation.As a result, the patient is scheduled to undergo bilateral explantation with no replacement breast prostheses on (b)(6) 2022.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2022, mentor received additional information about the event.An updated explantation date of (b)(6) 2022 was reported.D6b explantation month, day, and year: (b)(6) 2022 manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that the patient¿s right breast prosthesis ruptured post implantation.Mentor inadvertently did not include this information in the initial report.This report is for the patient's left breast prosthesis.Manufacturer¿s reference number: (b)(4).B5 event description: the statement "no device issue such as rupture was reported." should be removed.
Additional Manufacturer Narrative
On 19-jan-2023, mentor received additional information about the event.An updated explant date of (b)(6) 2022 was reported.On (b)(6) 2023, the patient was diagnosed with baker grade i capsular contracture in the left breast and right breast prosthesis rupture.No baker grade was provided for patient¿s right breast capsular contracture.Manufacturer¿s reference number: (b)(4).

• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15009439
• Report Number: 1645337-2022-08260
• Device Sequence Number: 6781435
• Product Code: FTR
• UDI-Device Identifier: 00081317005230
• UDI-Public: 00081317005230
• 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: 2016
• Device Explanted Year: 2022
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2020
• Device Model Number: 3341352
• Device Catalogue Number: 3341352
• Device Lot Number: 6903640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 07/15/2022; 01/19/2023
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 07/15/2022; 08/05/2022; 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2015
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White