MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MM+ 650CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3341505
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast augmentation revision with mentor memoryshape¿650cc silicone breast implants which patient believes her left side is ruptured, and as a result implant has dropped.Her right side has wrinkled and feels like a bubble.These issues occurred after implantation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left side.
Additional Manufacturer Narrative
On (b)(6) 2019, patient reported that after seeing her doctor , he didn't confirm deflation and just indicated that the implant had to be put back in the ¿pocket¿ which would require surgery.I had the surgery on (b)(6) and the breast seems to be dropping again.Will visit the doctor again in (b)(6).This report is for the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 8/20/2019, the codes were updated.The product experience code off label use added.Surgical intervention added for the patient code.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, additional information received indicated that the patient had issue with capsular contracture baker grade iii and surgeon cleaned out pocket and kept the same implants in patient.Date of procedure is unknown.No rupture as it was reported initially.The report indicated that just the left implant was reinserted note.Reusing the same implant is off label use.This report is for the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on september 10, 2024 indicated that the patient underwent bilateral removal on (b)(6) 2024.Reason for device explant and/or reoperation: capsular contracture grade iii, off label use, surgical intervention.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on september 9, 2024, indicated that the post-operation indicated that the right implant was rotated and had defect anteriorly.As a result, patient underwent right side with 695cc natrelle scf exchange, liposuction lateral axillary line, fat transfer breast, mesh reinforcement of attenuated capsule.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has 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
Follow up:( 6) mistakenly reported that the device was received by mentor even though the left device was not received.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ MM+ 650CC
• 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 ; 949789-8687
• MDR Report Key: 8691393
• Report Number: 1645337-2019-13697
• Device Sequence Number: 1857967
• Product Code: FTR
• UDI-Device Identifier: 00081317005384
• UDI-Public: 00081317005384
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/16/2019

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: 10/19/2020
• Device Catalogue Number: 3341505
• Device Lot Number: 6983393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/01/2019; 07/26/2019; 08/20/2019; 09/10/2024; 09/11/2024; 10/22/2024; 11/13/2024
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/11/2019; 08/14/2019; 09/09/2019; 09/11/2024; 09/12/2024; 10/23/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2015
• 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: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female