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

Model Number	3341105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/01/2021
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: capsular contracture.Explantation month, day, and year: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent a primary breast augmentation procedure with mentor memoryshape breast implant 255cc gel breast prostheses developed capsular contracture in both of her breasts post implantation (baker grade ii in left breast, baker grade iii in right breast).Bilateral capsular contracture was diagnosed by a healthcare professional.As a result, the patient is scheduled to undergo bilateral explantation on (b)(6) 2022.This medwatch report is for the patient¿s left breast prosthesis.
Event or Problem Description
It was reported that a (b)(6) asian female patient who underwent a primary breast augmentation procedure with mentor memoryshape breast implant 255cc gel breast prostheses developed capsular contracture in both of her breasts post implantation (baker grade ii in left breast, baker grade iii in right breast).Bilateral capsular contracture was diagnosed by a healthcare professional.As a result, the patient is scheduled to undergo bilateral explantation on (b)(6) 2022.This medwatch report is for the patient¿s left breast prosthesis.
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: capsular contracture.Explantation month, day, and year: (b)(6) 2022.(b)(4).
Additional Manufacturer Narrative
On 26-jan-2022, mentor received additional information about the event.It was previously reported that the patient was scheduled to undergo bilateral explantation on (b)(6) 2022.New information received states that explantation has been postponed.No updated explantation date was provided.Block b2 ¿is required intervention¿ no longer applies to this event.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
• 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: 13344829
• Report Number: 1645337-2022-00776
• Device Sequence Number: 16582344
• Product Code: FTR
• UDI-Device Identifier: 00081317005308
• UDI-Public: 00081317005308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 07/10/2021
• Device Model Number: 3341105
• Device Catalogue Number: 3341105
• Device Lot Number: 7348928
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2016
• 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: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian