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.  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 a ruptured right breast implant 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.
Additional Manufacturer Narrative
On june 08, 2023, mentor received additional information.Patient age at the time of event: 54 years old.The mammogram report was provided which indicated both breast implants were ruptured.As an complaint was indicated for the contralateral side, another file was generated to document the event.This report is for the right breast prosthesis.Refer to manufacturing report number 1645337-2023-07564 for the contralateral event.Manufacturer¿s reference number: (b)(4).
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 no damage or anomalies were observed on the breast implant.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.The event described could not be confirmed as the breast implant was returned without detectable gel exposure.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.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: 17080340
• Report Number: 1645337-2023-06742
• Device Sequence Number: 6345936
• 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,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): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 06/30/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/27/2023; 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