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

Catalog Number	33630022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject: (b)(6).Uk infinity total ankle system study.Gutter pain: increased pain reported around the ankle.Plain x rays show some potential gutter impingement.Spect ct scan ordered.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: INFINITY TALAR DOME SZ 2 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: 50222416
• Report Number: 3010667733-2026-01138
• Device Sequence Number: 12120743
• Product Code: HSN
• UDI-Device Identifier: 00840420122032
• UDI-Public: 00840420122032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 33630022
• Device Lot Number: 1637760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/12/2026
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 173 LB