MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	THPX455
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
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.Reason for device explant and/or reoperation: left capsular contracture; baker grade iii/iv.Date of explant: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent unspecified breast surgery with a 455cc mentor memorygel xtra breast implant on both sides and experienced bilateral capsular contracture; baker grade iii/iv.As a result, the devices will be explanted on (b)(6) 2021.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that incorrect common device name was mistakenly reported under the previous initial submission.It has been corrected on this form.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12021417
• Report Number: 1645337-2021-06766
• Device Sequence Number: 3426211
• Product Code: FTR
• UDI-Device Identifier: 00081317025726
• UDI-Public: 00081317025726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 08/19/2023
• Device Model Number: THPX455
• Device Catalogue Number: THPX455
• Device Lot Number: 7609613
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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