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

Model Number	3507555MC
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast surgery with implantation of a 555cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured right breast implant using ultrasound imaging.As a result, the patient underwent removal and replacement with 675cc mentor memorygel breast implants on (b)(6) 2022.
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: rupture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 17, 2022, the mentor analysis lab received the suspect medical device for evaluation.On june 23, 2022, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection and leak testing of the device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture status identified by mri evaluation includes both suspected ruptures, which are those ruptures identified by mri but not confirmed by explantation and examination of the device, and confirmed ruptures, which are those ruptures that are confirmed by evaluation of the explanted devices.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 24, 2022, mentor received additional information.Mammogram imaging results indicated that a medial palpable silicone lump of the right breast was present.However, during removal surgery, the right implant was intact and a such, rupture is no longer applicable to this file.Since a lump was present without rupture, gel bleed is appropriate.Additionally, malposition of the right implant was indicated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On december 15, 2022, mentor reevaluated the device per the updated adverse event.The following was added to the device evaluation.Leak testing was performed, in accordance with mentor procedures, and no leak sites or gel bleed were detected during the analysis.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14633743
• Report Number: 1645337-2022-06675
• Device Sequence Number: 17637471
• Product Code: FTR
• UDI-Device Identifier: 00081317004257
• UDI-Public: 00081317004257
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: 3507555MC
• Device Catalogue Number: 3507555MC
• Device Lot Number: 6912850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 11/24/2022; 12/15/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/05/2022; 12/14/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2015
• 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: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White