MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE MM+ 585CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341455
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/05/2020
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 (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: rupture, pain.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent breast reconstruction primary with a mentor memoryshape 585cc silicone prosthesis experienced bilateral discomfort and left sided rupture post procedure.The mri examination confirmed intracapsular rupture of the left breast implant, and intact right breast implant with stable trace peri-implant fluid.As a result, patient scheduled for bilateral replacements with mentor silicone implants on (b)(6) 2021.This report relates to the left prosthesis.
Additional Manufacturer Narrative
On january 18, 2021 additional information received indicated that the replacements devices are as follow:left breast: cat: shpx595, sn: (b)(6), right breast: cat: shpx595, sn: (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Suspect device was received on february 09 2021: device evaluation completed on february 11, 2021 the product was returned to mentor for evaluation.Mentor then conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample determined that a tear was found on the posterior view and extending to the anterior view aspect of the mentor memoryshape¿ mm+ 585cc breast implant, measuring approximately 14.2 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the anterior aspect, measuring less than 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with a variety of factors.Surgeons should instruct their patients to inform them if there is significant pain or if pain persists.Pain 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.Image evaluation completed on february 10, 2021 upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.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+ 585CC
• 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: 11127733
• Report Number: 1645337-2021-00156
• Device Sequence Number: 642535
• Product Code: FTR
• UDI-Device Identifier: 00081317005377
• UDI-Public: 00081317005377
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/17/2020

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: 10/10/2019
• Device Model Number: 3341455
• Device Catalogue Number: 3341455
• Device Lot Number: 6869234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/18/2021; 02/09/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/20/2021; 02/12/2021
• 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: 51 YR