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

Catalog Number	3341055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains the supplemental information for mentor psr reference number (b)(4).This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.Investigation summary: according to the information received, the patient developed capsular contracture associated with breast implant.During evaluation of the sample, it was observed to be intact.No additional anomalies were observed.Based on the findings, mentor analysis lab concluded that the reported issue is unrelated to the breast implant and related to the patient condition.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Based on the information reported and the product investigation, no corrective action will be taken at this time.No further investigation will be conducted on this complaint due to external cause.The reported complaint could not be confirmed.This report is not intended to deny that patients experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Reason for device explant and/or reoperation: bilateral capsular contracture (grade 3 for left and grade 3.5 for right).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This report contains the supplemental information for mentor psr reference number (b)(4).It was reported that a (b)(6) year old female patient underwent a primary breast augmentation with two 225cc mentor memoryshape breast implants and experienced postoperative bilateral capsular contracture (grade 3 for left and grade 3.5 for right).As a result, the patient underwent bilateral removal and replacement with two 225cc mentor memorygel breast implants (catalog #:3502251bc) on (b)(6) 2019.The grades on the bilateral capsular contracture were confirmed by a surgeon during the revision surgery on (b)(6) 2019.This report is for the left prosthesis.

• 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
• MDR Report Key: 9169023
• Report Number: 1645337-2019-21088
• Device Sequence Number: 3643557
• Product Code: FTR
• UDI-Device Identifier: 00081317005292
• UDI-Public: 00081317005292
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 04/25/2022
• Device Catalogue Number: 3341055
• Device Lot Number: 7460992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 10/08/2019
• 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
• Patient Age: 44 YR