MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	TRM-360
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of "capsular contracture " is a physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: ¿capsular contracture, baker grade unknown¿.
Event or Problem Description
Patient reported left side "joints ache all over her body, specifically her back and feet" which was not device related.Healthcare professional additionally reports left side capsular contracture, baker grade unknown, "recall allergan trm-textured implants" and ¿concerns about implant related illness." healthcare professional additionally reported ¿signs of systemic inflammation¿ which was not device related.Device has been explanted and discarded.
Additional Manufacturer Narrative
Visual device evaluation: "visual analysis of the photographs identified: device patch with lot number 2763481, red and white encapsulation.Device analysis performed through photographs.Due to the impossibility to perform microscopic analysis, it is not possible to determine the most likely failure mode.".
Event or Problem Description
Patient reported left side "joints ache all over her body, specifically her back and feet" which was not device related.Healthcare professional additionally reports left side capsular contracture, baker grade unknown, "recall allergan trm-textured implants" and ¿concerns about implant related illness." healthcare professional additionally reported ¿signs of systemic inflammation¿ which was not device related.Device has been explanted and discarded.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11570827
• Report Number: 9617229-2021-05860
• Device Sequence Number: 14352262
• Product Code: FTR
• UDI-Device Identifier: 10888628008113
• UDI-Public: 10888628008113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2020
• Device Model Number: TRM-360
• Device Catalogue Number: TRM-360
• Device Lot Number: 2763481
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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