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

Model Number	3541258
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); Wrinkling (2613)
Date of Event	03/14/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or 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.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 surgery with a mentor memoryshape breast implant 315cc gel breast prosthesis (left device) and a mentor memoryshape breast implant 355cc gel breast prosthesis (right device) is dissatisfied with the shape of her breasts.It was reported that the shape is not good and that there are bubbles.Additionally, the patient is feeling a high amount of discomfort in her breasts.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On 29-oct-2021, mentor received additional information about the event: an updated event date of (b)(6) 2014 was reported.The patient underwent a primary breast augmentation procedure with the suspect medical devices.The patient is scheduled to undergo bilateral explantation on (b)(6) 2021.Reason for device explant and/or reoperation: dissatisfaction with shape of breasts, discomfort in breasts.D6b explantation month, day, and year: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 10-jan-2024, mentor received additional information about the event: the patient was diagnosed with bilateral baker grade iv capsular contracture.It was previously reported that the patient was scheduled to undergo bilateral explantation on (b)(6) 2021.New information received states that explantation never took place and the device is still implanted in the patient.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: 12706049
• Report Number: 1645337-2021-11978
• Device Sequence Number: 11886856
• Product Code: FTR
• UDI-Device Identifier: 00081317005469
• UDI-Public: 00081317005469
• 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: 2014
• 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): 10/07/2021

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: 07/31/2018
• Device Model Number: 3541258
• Device Catalogue Number: 3541258
• Device Lot Number: 6742873
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 10/29/2021; 01/10/2024
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/17/2021; 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2013
• 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; Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White