MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MM+ 650CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent an unspecified breast surgery with a mentor memoryshape, 650cc silicone breast implant experienced left-sided asymmetry issue postoperatively.As a result, patient scheduled for removal on (b)(6) 2022.
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: asymmetry issue.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on february 8, 2022 indicated that the patient age at the time of event was 72 years old, ethnicity caucasian.Patient underwent replacement with natrelle silicone breast implant.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Suspect device received on (b)(6) 2022 device evaluation completed on (b)(6) 2022: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the mentor memoryshape¿ mm+ 650cc returned device.Asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ MM+ 650CC
• 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: 13283181
• Report Number: 1645337-2022-00527
• Device Sequence Number: 4900449
• Product Code: FTR
• UDI-Device Identifier: 00081317005384
• UDI-Public: 00081317005384
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,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: 10/19/2021
• Device Model Number: 3341505
• Device Catalogue Number: 3341505
• Device Lot Number: 7386853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/08/2022; 02/18/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/16/2022; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2016
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White