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

Model Number	3341309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Autoimmune Disorder (1732)
Date of Event	01/01/2018
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: autoimmune disorder.Explantation date: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported via 5102135 that a (b)(6) year-old caucasian female patient underwent a breast surgery with two 445cc mentor memoryshape breast implant prostheses and experienced autoimmune disorder postoperatively.The patient suffered several unexplained systemic symptoms, including health decline, weakness, fatigue, tremors, neurological motor issues, memory loss, lack of concentration, decreased libido, breast pain, insominia, joint pain, limited mobilitty, systemic lupus erythematosus (sle), sinus issues, skin rash, migraines, hair loss, vision disturbances, mood changes, inflammation, and positive ana.No device issue was reported.The root cause of the patient¿s symptoms is unclear.As a result, the patient is scheduled to undergo explantation on (b)(6) 2021.The event date was estimated as (b)(6) 2018 based on available information.This report is for the right-sided prosthesis.

• 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
• MDR Report Key: 12485641
• Report Number: 1645337-2021-10369
• Device Sequence Number: 19817472
• Product Code: FTR
• UDI-Device Identifier: 00081317005094
• UDI-Public: 00081317005094
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: 09/14/2021
• Device Model Number: 3341309
• Device Catalogue Number: 3341309
• Device Lot Number: 7375130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR