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

Model Number	SMPX685
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: left breast infection.(b)(4).
Event or Problem Description
It was reported that a female patient who underwent a breast reconstruction procedure with a mentor memorygel breast implant 685cc gel breast prosthesis developed an infection in her left breast.As a result, the patient underwent explantation with no replacement device on (b)(6) 2020.
Additional Manufacturer Narrative
On 13-nov-2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced infection.During the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.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 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.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Infection complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, 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 (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.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 WORLDWIDE LLC; 33 technology drive; irvine 92618
• MDR Report Key: 10658394
• Report Number: 1645337-2020-12844
• Device Sequence Number: 3219871
• Product Code: FTR
• UDI-Device Identifier: 00081317025160
• UDI-Public: 00081317025160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2020

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: 10/25/2023
• Device Model Number: SMPX685
• Device Catalogue Number: SMPX685
• Device Lot Number: 7646578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/13/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/09/2020; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention