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

Model Number	3341455
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
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: anaplastic large cell lymphoma.(b)(4).
Event or Problem Description
It was reported from the united states that a female patient of an unknown age and ethnicity who had a 585cc mentor memoryshape breast implant placed was diagnosed with anaplastic large cell lymphoma of the right breast on an unknown date.As a result, the patient underwent explantation of the device on (b)(6) 2020.No device issue such as rupture was reported.Despite multiple attempts to obtain more in-depth information on the specific details of this event, no additional event details have been made available to mentor at this time.If additional event details are made available in the future, then a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2020.Seroma fluid, breast capsule, and the right breast were tested and were all negative for anaplastic large cell lymphoma.No further information was provided.H6 was updated to reflect seroma.Patient code 3264 originally reported is no longer applicable.Reason for device explant and/or reoperation: seroma manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: 10687794
• Report Number: 1645337-2020-12797
• Device Sequence Number: 17083785
• Product Code: FTR
• UDI-Device Identifier: 00081317005377
• UDI-Public: 00081317005377
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: 3341455
• Device Catalogue Number: 3341455
• Device Lot Number: 7360128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: Life Threatening; Required Intervention