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

Model Number	SMPX755
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/01/2021
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: left capsular contracture; baker grade iii.Date of explant: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent unspecified breast surgery with a 755cc mentor memorygel breast implant and experienced capsular contracture; baker grade iii on her left side postoperatively.As a result, the device will be explanted on (b)(6) 2021.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the procedure type was primary augmentation, and date of unilateral replacement surgery with catalog number smpx755 (order placed) is moved to (b)(6) 2021.Field d6b for explantation date is (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 6, 2021, mentor became aware that the surgeon removed capsule and re-implanted same implant.Hence, health impact code "surgical intervention", and device problem code "off-label use" were added to section h on this form.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 4, 2021, mentor received confirmation that re-augmentation with capsulectomy was done on the 5th of october but the doctor used the original implant so the warranty is void is what i was told.He was not aware that he needed to use a new implant.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL 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: 12461220
• Report Number: 1645337-2021-10093
• Device Sequence Number: 19814527
• Product Code: FTR
• UDI-Device Identifier: 00081317025177
• UDI-Public: 00081317025177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2021

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: 04/05/2025
• Device Model Number: SMPX755
• Device Catalogue Number: SMPX755
• Device Lot Number: 9452310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 10/06/2021; 11/04/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/04/2021; 10/26/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2020
• 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: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White