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

Model Number	3547007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	01/01/2019
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: material rupture, local reaction.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient, who's undergone breast augmentation revision with two 700cc mentor memorygel breast implants, suffered spontaneous bilateral breast implant ruptures, post-procedure.The ruptures were diagnosed via an mri.As a result, the patient underwent bilateral capsulorrhaphy, bilateral removal and then bilateral replacement on (b)(6) 2021.The capsules were described to be abnormal and were sent to pathology.The replacement devices were the following: (right) 800cc mentor smooth round moderate plus profile saline catalog: 3502800 lot: 9550486 sn: (b)(4) and (left) 800cc mentor smooth round moderate plus profile saline catalog: 3502800 lot: 9550486 sn: (b)(4).This medwatch form is for the left breast prosthesis.Complications on the right breast/implant was reported under mrn: 1645337-2021-03145.

• Brand Name: MENTOR MEMORYGEL 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: 11742635
• Report Number: 1645337-2021-04693
• Device Sequence Number: 17143267
• Product Code: FTR
• UDI-Device Identifier: 00081317000761
• UDI-Public: 00081317000761
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 06/21/2009
• Device Model Number: 3547007
• Device Catalogue Number: 3547007
• Device Lot Number: 5539449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/28/2021
• 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: 71 YR