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

Model Number	3341109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a - the patient has not undergone explantation and/or reoperation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient who underwent an unspecified breast augmentation with 270cc mentor memoryshape breast implants experienced abnormal mammogram and ultrasounds postoperatively.The patient reported having concerns with textured implants, and planning to undergo breast implant prophylactic removal to avoid injury.At the time of this report, mentor has received no information regarding an expected explantation date.This medwatch report is for the left-sided implant.
Additional Manufacturer Narrative
Mentor received additional event information from the patient that she will undergo explantation in (b)(6) 2022, the patient is unsure of the exact explantation date.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 24-jun-2022, mentor received additional information about the event.The patient was diagnosed with baker grade iv capsular contracture in her left breast.This medwatch report is for the patient¿s left breast prosthesis.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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11118457
• Report Number: 1645337-2021-00063
• Device Sequence Number: 11661693
• Product Code: FTR
• UDI-Device Identifier: 00081317005056
• UDI-Public: 00081317005056
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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: 11/17/2021
• Device Model Number: 3341109
• Device Catalogue Number: 3341109
• Device Lot Number: 7397570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 06/24/2022
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/26/2021; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2016
• 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