MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC POLY INSERT SIZE 3-2 6MM INCOMPASS TOTAL ANKLE SYSTEM; Prosthesis, ankle, semi-constrained, cemented, metal/polymer

Catalog Number	33853206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Subject: (b)(6) incompass total ankle study.Delayed wound healing subject experience incision dehiscence and slough development.Additional information received on 11 june 2026: the patient underwent a left total ankle wound dehiscence, debridement, and ehl (extensor hallucis longus) tenosynovectomy.

• Brand Name: POLY INSERT SIZE 3-2 6MM 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: 25746013
• Report Number: 3010667733-2026-00912
• Device Sequence Number: 15974224
• Product Code: HSN
• UDI-Device Identifier: 00889797114349
• UDI-Public: (01)00889797114349(11)250613(17)220613(10)1815019
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 08/06/2026

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: 33853206
• Device Lot Number: 1815019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 229 LB