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

Model Number	3542757
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/22/2021
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.The manufacturing record evaluation (mre) of lot number 409205 was requested to the quality operations team.However, the physical file of the dhr was not found.It is possible that the lot number provided is not valid.Should additional information become available, mentor will submit a supplemental report accordingly.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.  this report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.  this report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.  if certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a primary breast augmentation surgery with implantation of a 275cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with bilaterally ruptured breast implants using mammogram imaging.As a result, the patient underwent bilateral removal and replacement with 225cc mentor smooth round moderate profile saline breast implants on (b)(6) 2023.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2023-06742 for the contralateral event.
Additional Manufacturer Narrative
On june 30, 2023, the mentor analysis lab received the suspect medical device for evaluation.On july 06, 2023, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.Visual analysis of the returned sample revealed that the breast implant was found to have two (2) tears on the posterior view, measuring approximately 1.7 cm, and 2 cm.Because of the class action and concerns of possible spoliation of evidence, mentor is prohibited from conducting a further physical evaluation of this covered device.Mentor performs 100% inspection of all devices prior to release, product evaluation concluded that the tear occurred sometime subsequent to the removal of the device from its protective packaging.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17209833
• Report Number: 1645337-2023-07564
• Device Sequence Number: 6741657
• Product Code: FTR
• UDI-Device Identifier: 00081317000662
• UDI-Public: 00081317000662
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1991
• Device Explanted Year: 2023
• 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 Model Number: 3542757
• Device Catalogue Number: 3542757
• Device Lot Number: 409205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White