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

Model Number	SMPX645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Breast Mass (2439)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deformity, sensory neuroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent breast reconstruction with a (right) 800cc mentor memorygel breast implant and a (left) 645cc mentor memorygel breast implant.Post-operatively, the patient was diagnosed with bilateral breast deformities and left breast sensory neuroma.As a result, the patient underwent removal and replacement surgery on (b)(6), 2022.During surgery, it was discovered that the right breast implant was ruptured.Subsequently, both implants were replaced with the following: (right) 500cc mentor artoura plus, smooth, high profile catalog: sdc135h lot: 9587144 sn: (b)(4) and (left) 500cc mentor artoura plus, smooth, high profile catalog: sdc135h lot: 9632963 sn: (b)(4).This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On march 30, 2022, mentor became aware that the patient also underwent bilateral capsulectomy on (b)(6) 2022.On (b)(6) 2022, the product investigation was completed.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.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the smooth mod + prof xtra 645cc returned device.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
On march 31, 2022, mentor became aware that the incorrect date of implantation was erroneously indicated in the initial report sent on (b)(6) 2022.The correct date has been filled.Section d.6a.: (b)(6) 2018.

• 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: 13911874
• Report Number: 1645337-2022-03358
• Device Sequence Number: 14469271
• Product Code: FTR
• UDI-Device Identifier: 00081317025153
• UDI-Public: 00081317025153
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 04/03/2023
• Device Model Number: SMPX645
• Device Catalogue Number: SMPX645
• Device Lot Number: 7569713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 03/31/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/14/2022; 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2018
• 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: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White