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

Model Number	SHPX235
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a.Manufacturer¿s reference number: pc-(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast augmentation primary with a mentor memorygel breast implant 235cc and suffered from a rupture on the right side.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the date of surgery is (b)(6) 2021.Hence, following fields have been updated on this form: - is required intervention has been selected under section b; field b2 - fields d6b for explantation date have been updated to august 31, 2021.- field h6 health effect - impact code ¿device explantation¿ has been added - field h6 type of investigation has been updated to "device not returned" reason for device explant and/or reoperation: right rupture 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 16, 2021, mentor became aware that the patient experienced right side rupture and capsular contracture; baker grade iv, and left side device migration and cutaneous contour deformity.The devices were explanted on (b)(6) 2021.Field d6b has been updated to (b)(6) 2021, and clinical code capsular contracture has been added to this form.Reason for device explant and/or reoperation: right rupture, and capsular contracture; baker grade iv this supplemental medwatch report is for the patient¿s right-sided device.Left side issue is being reported separately.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 TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11873053
• Report Number: 1645337-2021-05799
• Device Sequence Number: 3269244
• Product Code: FTR
• UDI-Device Identifier: 00081317025214
• UDI-Public: 00081317025214
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: SHPX235
• Device Catalogue Number: SHPX235
• Device Lot Number: 7496481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 11/16/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 09/09/2021; 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2017
• 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; Other
• Patient Age: 38 YR
• Patient Sex: Female