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

Model Number	3341055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/30/2021
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: wound infection.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent an unspecified breast reconstruction with 225cc mentor memoryshape breast implant experienced left-sided wound infection postoperatively.As a result, the patient underwent explantation on (b)(6) 2021.
Additional Manufacturer Narrative
Mentor received additional information regarding patient details.Information has been updated accordingly.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 29, 2021, mentor became aware that the suspect medical device was implanted for primary breast reconstruction.The serial number was (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 18, 2022, mentor received additional information indicating that the patient's left breast implant was replaced with another 225cc mentor memoryshape breast implant (catalog: 3341055 lot: 7548689 sn: (b)(6)) on (b)(6) 2021.Mentor also became aware that the patient also suffered wrinkling on the right breast post-procedure and had to undergo surgical intervention.The patient had fat grafting/nipple reconstruction on (b)(6) 2021.This will be reported under mrn: 1645337-2022-01560.Lastly, the patient also experienced wrinkling on the left breast after the replacement surgery done on (b)(6) 2021.The wrinkling on the left breast was diagnosed on (b)(6) 2021 and also required surgical intervention.The patient had fat grafting/nipple reconstruction on (b)(6) 2021.This will be reported under mrn: 1645337-2022-01561.

• 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: 11882218
• Report Number: 1645337-2021-05877
• Device Sequence Number: 16491204
• Product Code: FTR
• UDI-Device Identifier: 00081317005292
• UDI-Public: 00081317005292
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2021

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: 02/21/2023
• Device Model Number: 3341055
• Device Catalogue Number: 3341055
• Device Lot Number: 7548689
• 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: 04/29/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 11/29/2021; 01/18/2022
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/27/2021; 12/15/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2018
• 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
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian