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

Model Number	SMHX700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	02/01/2022
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.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.Reason for device explant and/or reoperation: early onset seroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 29-year-old hispanic/latino female patient underwent a breast surgery with implantation of a 700cc mentor memorygel xtra breast implant prosthesis.Post-operatively, the patient was diagnosed with an early onset seroma of the left breast by a medical professional.As a result, the patient underwent unilateral removal without replacement on (b)(6) 2022.
Additional Manufacturer Narrative
On may 18, 2023, mentor received additional information.The patient developed an infection of the left breast, implant exposure, and discharge in the affected area in (b)(6) 2022.As such the date of event was updated to (b)(6) 2022.Reason for device explant and/or reoperation: wound infection, pocket erosion.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 19, 2023, mentor determined that the received lot 9546496, which was received on june 05, 2023, is the suspect medical device.As such, the lot number has been updated.The size, brand name, and catalog are the same for both device.Lot: 9546496 on june 27, 2023, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.During visual evaluation, no apparent damage or visual anomalies were observed on the breast implant device.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.Infection, manifested by swelling, tenderness, pain, and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If the infection does not subside promptly with the appropriate treatment, removal of the implant is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.Extrusion may occur when the wound has not closed or when the tissue covering the implants weakens.The incidence of extrusion has been shown to increase when undue pressure is applied on the tissue located over the device, trauma to surrounding tissues may lead to thrombosis, delayed wound healing, improper size, placement, larger sized implants, use of steroids in the surgical pocket and microwave diathermy.Radiation therapy has been reported to increase the likelihood of extrusion.Extrusion may require additional surgery and possible removal of the implant, which may result in additional scarring and/or loss of breast tissue.A manufacturing record evaluation (mre) was performed for 9546496, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA 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: 16938634
• Report Number: 1645337-2023-05770
• Device Sequence Number: 17646601
• Product Code: FTR
• UDI-Device Identifier: 10081317027925
• UDI-Public: 10081317027925
• 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: 2021
• 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: 03/07/2026
• Device Model Number: SMHX700
• Device Catalogue Number: SMHX700
• Device Lot Number: 9546496
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 05/18/2023; 06/19/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/08/2023; 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic