MAUDE Adverse Event Report: Wright Medical Technology Inc TALAR DOME FLAT CUT SIZE 2 INCOMPASS TOTAL ANKLE SYSTEM; Prosthesis, ankle, semi-constrained, cemented, metal/polymer

Catalog Number	33850032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Urinary Tract Infection (2120)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject: 007-006 incompass total ankle study sepsis the patient began experiencing fever and chills on (b)(6) 2026.The condition progressed, resulting in an emergency department visit and subsequent hospitalization for sepsis secondary to a urinary tract infection (uti).The patient was treated with antibiotics and a foley catheter.The patient was discharged from the hospital on (b)(6) 2026 following resolution of the event.Related to procedure: probably.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: TALAR DOME FLAT CUT SIZE 2 INCOMPASS TOTAL ANKLE SYSTEM
• Common Device Name: Prosthesis, ankle, semi-constrained, cemented, metal/polymer
• Manufacturer (Section D): Wright Medical Technology Inc; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): Wright Medical Technology, Inc.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50364644
• Report Number: 3010667733-2026-01167
• Device Sequence Number: 10690209
• Product Code: HSN
• UDI-Device Identifier: 00889797113632
• UDI-Public: 00889797113632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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: Lay User/Patient
• Device Catalogue Number: 33850032
• Device Lot Number: 1833831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male
• Patient Weight: 192 LB