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

Model Number	3544250
Medical Device Problem Codes	Material Rupture (1546); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2021, upon visual evaluation of the image provided in the complaint received on (b)(6) 2021, the implant was observed ruptured.As the product involved in this complaint was not received, the device couldn¿t be analyzed according to our procedures.As part of mentors quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.Manufacturers reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision with a mentor memorygel breast implant 250cc and suffered from a bilateral rupture.As a result, the patient had undergone removal and replacement with mentor memorygel breast implant 440cc on (b)(6) 2021.This medwatch is for the left side.
Additional Manufacturer Narrative
Suspect device received on (b)(6) 2021.Device evaluation completed on (b)(6) 2021: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.Visual inspection of the returned sample determined that a tear was observed on the posterior view of the siltex hpg, 250cc breast implant, measuring approximately 6.1 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the posterior view, 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information received with the device indicated that patient underwent bilateral replacements as follow: l/cat#: smpx440, sn#: (b)(6), r/ cat#: smpx440, sn#: (b)(6).Manufacturer¿s reference number: (b)(4).

• 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: 12379679
• Report Number: 1645337-2021-09624
• Device Sequence Number: 3964399
• Product Code: FTR
• UDI-Device Identifier: 00081317001027
• UDI-Public: 00081317001027
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 12/31/2015
• Device Model Number: 3544250
• Device Catalogue Number: 3544250
• Device Lot Number: 6429729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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: 31 YR