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

Model Number	3542757MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the device's photo was completed: upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: material rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient, who's undergone breast augmentation revision with two 275cc mentor memorygel breast implants, suffered bilateral breast implant ruptures, post-procedure.The ruptures were diagnosed via an ultrasound examination.As a result, the patient bilateral removal and replacement on (b)(6) 2021.The replacement devices were: (left) 190cc mentor memorygel breast implant catalog: 3507190mc lot: 9594306 sn: (b)(4) and (right) 190cc mentor memorygel breast implant catalog: 3507190mc lot: 9594306 sn: 9594306-004.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On december 7, 2021, the mentor failure analysis lab received the device for evaluation.On december 27, 2021, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sx mod classic gel 275cc breast implant had an area of siltex cracking on the posterior view.Additionally, a tear with a length of 0.3 cm was observed within the siltex cracking area.The evaluation determined that the cause of the rupture was consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stress.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12929054
• Report Number: 1645337-2021-13442
• Device Sequence Number: 14856720
• Product Code: FTR
• UDI-Device Identifier: 00081317004387
• UDI-Public: 00081317004387
• 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 Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2021

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: 05/31/2017
• Device Model Number: 3542757MC
• Device Catalogue Number: 3542757MC
• Device Lot Number: 6592277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2012
• 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: 52 YR
• Patient Sex: Female