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

Model Number	3507555MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) hispanic female patient, who's undergone primary breast augmentation with two 555cc mentor memorygel breast implants, suffered right breast implant rupture, post-procedure.The patient was reportedly involved in an auto accident.The rupture was diagnosed via cat scan.As a result, the patient underwent bilateral removal and replacement on (b)(6) 2021.The replacements were: (right) 650cc mentor memorygel breast implant catalog: 3506504bc lot: 7666803 sn: (b)(4) and (left) 650cc mentor memorygel breast implant catalog: 3506504bc lot: 9526990 sn: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) hispanic female patient, who's undergone primary breast augmentation with two 555cc mentor memorygel breast implants, suffered right breast implant rupture, post-procedure.The patient was reportedly involved in an auto accident.The rupture was diagnosed via cat scan.As a result, the patient underwent bilateral removal and replacement on (b)(6) 2021.The replacements were: (right) 650cc mentor memorygel breast implant catalog: 3506504bc lot: 7666803 sn: (b)(4) and (left) 650cc mentor memorygel breast implant catalog: 3506504bc lot: 9526990 sn: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted the visual inspection.Visual analysis of the returned sample revealed that the sm mod classic gel, 555cc breast implant was found to be ruptured.The evaluation determined that the cause of the rupture is the trauma experienced.Rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Trauma is a known inherent risk of the gel-filled mammary prosthesis.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• 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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13239328
• Report Number: 1645337-2022-00411
• Device Sequence Number: 4547879
• Product Code: FTR
• UDI-Device Identifier: 00081317004257
• UDI-Public: 00081317004257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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

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: 11/30/2018
• Device Model Number: 3507555MC
• Device Catalogue Number: 3507555MC
• Device Lot Number: 6777810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic