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

Catalog Number	3507600BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/23/2024
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.Since no lot number was provided, no manufacturing record evaluation could be performed.D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Reason for device explant and/or reoperation: left rupture.D6b explantation date: on (b)(6) 2024.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 58-year-old caucasian female patient underwent breast surgery with unknown size unknown gel implants on both sides and experienced bilateral breast implant ruptures postoperatively; diagnosed in the office via mri.The patient has consulted with the healthcare professional.As a result, the patient is scheduled for surgery on (b)(6) 2024.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On october 24, 2024, mentor became aware that the replacement devices used on (b)(6) 2024 were catalog number: 3503501bc; serial number: (b)(6) on the left side, and with catalog number: smhx430, serial number: (b)(6) on the right side.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On december 26, 2024, device evaluation was completed as follows: mentor conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that the gel mod-rnd 600cc breast implant was ruptured and received in two parts.In addition, shell abrasion was observed at the edges of the rupture.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Mentor is aware that the date of implant ((b)(6) 2003)i s prior to the manufacturing date (8/1/2003) of reported lot number 266316.If additional information becomes available, it will be updated and supplemental report will be submitted.This supplemental medwatch report is for the patient¿s side with visible lot number 266316.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 28, 2024, the mentor failure analysis lab received two 600cc devices for evaluation.One with lot number 266316, and the other was unknown.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Per device received, the following information has been updated on this form: - field d1 for brand name has been updated to "mentor smooth round high profile".- field d4 for catalog number has been updated to "3507600bc".- field d4 for lot number has been updated to "266316".- field d4 for unique identifier( udi) has been updated to "(b)(4)".A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.This supplemental medwatch report is for the patient¿s side with visible lot number 266316.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: 19917965
• Report Number: 1645337-2024-09025
• Device Sequence Number: 12790612
• Product Code: FTR
• UDI-Device Identifier: 00081317000174
• UDI-Public: 00081317000174
• 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: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Expiration Date: 08/31/2008
• Device Catalogue Number: 3507600BC
• Device Lot Number: 266316
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 11/28/2024; 12/26/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/25/2024; 12/13/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2003
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White