MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MH 685CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3341452
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263); Skin Inflammation/ Irritation (4545); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Safety note: impacted product number: ip-(b)(4).Mentor memoryshape¿ mh 685cc gel implants left breast notes: it was reported, via a health care professional report, that a female patient who underwent breast augmentation surgery with mentor memoryshape¿ mh 685cc mentor gel breast implants on (b)(6) 2016.Bia-alcl was observed on an unknown date from pathology findings of guided needle aspiration ¿ ¿patient positive for bia-alcl¿.Implant removal is scheduled for (b)(6) 2024.
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: alcl, skin inflammation, lymphoma.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).
Additional Manufacturer Narrative
Additional information received on sept 26, 2024, indicated that the patient underwent replacements with unspecified mentor silicone implants.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Safety note: impacted product number: (b)(4) mentor memoryshape¿ mh 685cc gel implants left breast notes: it was reported, via a healthcare professional report, that a female patient who underwent breast augmentation surgery with mentor memoryshape¿ mh 685cc mentor gel breast implants on (b)(6) 2016.Late onset seroma was observed on or about (b)(6) 2024 during surgical removal of the implants ¿ ¿findings: bilateral intact breast implants, seroma of left breast¿.Bilateral implant removal was performed on (b)(6) 2024.The patient underwent bilateral capsulectomy, and bilateral replacements as follow: left/ cat: shpb775, sn: (b)(6), right/cat: shpb775, sn: (b)(6) and evacuated 80 ml of seroma fluid from the left side.The fluid sent to cytology.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Upon further review done on 05-nov-2024, the pc skin reaction was removed from (b)(4).Per the information provided, the redness reported is related to the swelling (late-onset seroma).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ MH 685CC
• 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: 20263660
• Report Number: 1645337-2024-10976
• Device Sequence Number: 20898361
• Product Code: FTR
• UDI-Device Identifier: 00081317005254
• UDI-Public: (01)00081317005254(11)161118(17)211117(10)7397593
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2021
• Device Catalogue Number: 3341452
• Device Lot Number: 7397593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/14/2024; 11/05/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/08/2024; 10/18/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2016
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White