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

Model Number	TMPX295
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/09/2021
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: device migration.An analysis of the suspect medical device's photo was completed: investigation summary: upon visual evaluation of the image provided in the complaint, the siltex mod+prof xtra 295cc breast implant was observed with no apparent damage or visual anomalies.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient, who's undergone primary breast augmentation with a 295cc mentor memorygel xtra breast implant on the right breast on (b)(6) 2021, suffered right breast implant displacement/migration, post-procedure.The displacement/migration was diagnosed via an ultrasound on the same day ((b)(6) 2021.Subsequently, the patient underwent implant explantation and replacement with a 270cc mentor memorygel xtra breast implant (tmpx270 lot: 7624729 sn: (b)(4)).
Additional Manufacturer Narrative
On july 30, 2021, the mentor failure analysis lab received the device for evaluation on august 10, 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.During the visual evaluation, no apparent damage or visual anomalies were observed on the siltex mod+prof xtra 295cc returned device.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.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 XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11741856
• Report Number: 3006942524-2021-00009
• Device Sequence Number: 19714649
• Product Code: FTR
• UDI-Device Identifier: 00081317025450
• UDI-Public: 00081317025450
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 09/03/2023
• Device Model Number: TMPX295
• Device Catalogue Number: TMPX295
• Device Lot Number: 7623515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR