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

Catalog Number	3341109
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); No Code Available (3191)
Date of Event	03/19/2019
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: breast pain, device migration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent breast augmentation with two 270cc mentor memoryshape breast implants, suffered right side capsular contracture baker grade iii and bilateral breast pain post-operatively.It was also reported that the implants appeared to be rotated, especially on the left.As a result, the patient was scheduled for implant explantation on (b)(6) 2019.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On 6/14/2019, mentor became aware that the patient was scheduled for implant explantation on (b)(6) 2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 7/12/2019, the mentor failure analysis lab has 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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, mentor became aware that the patient experienced bilateral capsular contracture.The patient also had capsular contracture baker grade unknown on the left side.This medwatch form is for the left breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 7/30/2019, the product investigation was completed.Device investigation summary: during evaluation of the sample it was observed to be intact.No anomalies were observed.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.This report is not intended to deny that you 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.Manufacturer¿s reference number: (b)(4).

• 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: 8614204
• Report Number: 1645337-2019-11991
• Device Sequence Number: 16609367
• Product Code: FTR
• UDI-Device Identifier: 00081317005056
• UDI-Public: 00081317005056
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: 3341109
• Device Lot Number: 7295471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/14/2019; 06/26/2019; 07/12/2019; 07/30/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/18/2019; 07/02/2019; 07/19/2019; 08/01/2019
• 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: 56 YR