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

Catalog Number	3341402
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Wrinkling (2613)
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 mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent breast augmentation, as part of a clinical study, with two 620cc mentor memoryshape breast implants.Post-operatively, the patient was dissatisfied due to breast wrinkling on an unspecified breast.In addition, the patient was also diagnosed with bilateral breast implant displacement.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Since it was not specified which breast side had the wrinkling, it will be reported under the right side for now.A supplemental report will be submitted when clarifying information is obtained.This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2024, the mentor failure analysis lab received the device for evaluation.Mentor became aware that the patient has undergone breast implant removal surgery on (b)(6) 2024.Reason for device explant and/or reoperation: wrinkling, device migration on (b)(6) 2024, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the mentor memoryshape¿ mh 620cc returned device.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.Wrinkling is reported to occur more frequently in patients with one or more of the following: thin-skinned patients, patients with little or no subcutaneous fat, sub-glandular rather than submuscular placement, an implant that is too large relative to the breast pocket size or frame of the patient, overlying tissue that is minimal or of poor quality, and/or when capsular contracture is present.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.
Additional Manufacturer Narrative
On august 22, 2024, mentor received additional information indicating that the patient also suffered anisomastia on the right breast.In addition, the patient's implants were replaced with the following devices: (right) 500cc mentor memorygel breast implant catalog: 3505001bc, lot: 9981588, sn: (b)(6) and (left) 340cc mentor memorygel breast implant catalog: 3507340mc, lot: 9394060 sn: (b)(6).

• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19480737
• Report Number: 1645337-2024-06883
• Device Sequence Number: 8139284
• Product Code: FTR
• UDI-Device Identifier: 00081317005247
• UDI-Public: 00081317005247
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2021
• Device Catalogue Number: 3341402
• Device Lot Number: 7298516
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 07/25/2024; 08/22/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/13/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2016
• 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: Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White