MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE LM+ 290CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/15/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: baker¿s grade unknown capsular contracture.Manufacturer¿s reference number: pc-(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent breast augmentation revision with a 290cc mentor memoryshape silicone breast prosthesis experienced bilateral baker¿s grade unknown capsular contracture post procedure.Th issue was diagnosed through patients¿ symptoms.As a result, the patient schedule for bilateral replacements on (b)(6) 2021.This report relates to the right side.
Additional Manufacturer Narrative
Updated device evaluation completed on august 20, 2021: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the gel of the mentor memoryshape¿ lm+ 290cc breast implant was found to be fragmented.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 07, 2021 1 additional information received indicated that the capsular contracture grade is iii-iv.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Suspect device received on july 27 2021.Device evaluation completed on july 28, 2021.Visual analysis of the returned sample revealed that the gel of the mentor memoryshape¿ lm+ 290cc breast implant was found to be fragmented.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021 additional information received indicated that the patient underwent replacements with 325 cc moderate profile plus silicone gel style 1000 smooth wall devices.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE LM+ 290CC
• 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: 12096949
• Report Number: 1645337-2021-07400
• Device Sequence Number: 4826977
• Product Code: FTR
• UDI-Device Identifier: 00081317004936
• UDI-Public: 00081317004936
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/01/2021

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: 03/08/2022
• Device Model Number: 3341207
• Device Catalogue Number: 3341207
• Device Lot Number: 7438145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/06/2021; 07/16/2021; 07/27/2021; 07/30/2021; 08/20/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/12/2021; 07/23/2021; 07/30/2021; 08/02/2021; 08/23/2021
• 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: 50 YR