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

Model Number	3341152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Local Reaction (2035)
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: local reaction, suspected rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with a 345cc mentor memoryshape breast implant and experienced a local reaction and a suspected rupture on the left side post-operatively.As a result, the patient underwent explantation and replacement with two mentor memorygel breast implants on (b)(6) 2020.
Additional Manufacturer Narrative
On march 17, 2021, the mentor failure analysis lab received the device for evaluation.On march 28, 2021, mentor completed evaluation of the device.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the mentor memoryshape¿ mh 345cc returned device.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: rupture status identified by mri evaluation includes both suspected ruptures, which are those ruptures identified by mri but not confirmed by explantation and examination of the device, and confirmed ruptures, which are those ruptures that are confirmed by evaluation of the explanted devices.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A skin reaction is a noticeable change in the texture and/ or color of the skin.This can include bumps, scales, pustules or redness that can be inflamed, irritated, painful, or itchy.This can be due to a variety of factors such as infections, heat, allergens or immune system disorders.A second product was received 7480984 lot number.No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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
• MDR Report Key: 11475477
• Report Number: 1645337-2021-02642
• Device Sequence Number: 17190767
• Product Code: FTR
• UDI-Device Identifier: 00081317005193
• UDI-Public: 00081317005193
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2022
• Device Model Number: 3341152
• Device Catalogue Number: 3341152
• Device Lot Number: 7465186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/29/2021
• 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: 47 YR