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

Model Number	3542251
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/05/2021
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.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: suspicion of material rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent primary breast augmentation with two 225cc mentor memorygel breast implants.Post-operatively, the patient's doctor assumed that the patient's implants were ruptured.As a result, the patient underwent removal surgery on (b)(6) 2021.The implants were discovered to be not ruptured, however, the implants have dots on them.The implants were not replaced.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2021, the mentor failure analysis lab 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On december 1, 2021, an analysis of the device's photo was completed.Upon visual evaluation of the image provided in the complaint, black dots were perceived in the implant.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 16, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection and leak test of the returned device and material evaluation.Visual analysis of the returned sample revealed that the sx mpp gel 225cc breast implant had an area of siltex cracking on the posterior view.Also, yellow material was observed within the shell.Leak testing was performed, according with mentor procedure, and it revealed a tear within the siltex cracking, measuring approximately 0.1 cm.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional analysis was performed to identify the composition of the material and it revealed they were primarily composed of primarily composed of a biological-based material, with residues of pdms material (presumably derivate from the implant material since the particle was embedded).The mentor microbiology department provided the sterility assurance records of the implanted device.The lot met all the sterilization parameters required to provide sterility assurance prior to release for distribution.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: 12898958
• Report Number: 1645337-2021-13193
• Device Sequence Number: 4827582
• Product Code: FTR
• UDI-Device Identifier: 00081317000839
• UDI-Public: 00081317000839
• 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: 2012
• 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,Followup,Followup
• Report Date (Section B): 11/02/2021

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: 05/31/2016
• Device Model Number: 3542251
• Device Catalogue Number: 3542251
• Device Lot Number: 6476037
• 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): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 12/07/2021; 02/16/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/02/2021; 12/30/2021; 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2011
• 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: 57 YR
• Patient Sex: Female