MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 3 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33650003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Subject: (b)(6) uk infinity® total ankle system study.Pain and reduced mobility right ankle narrative of adverse event: : at clinic (b)(6) 2024 patient reported 3 month history of pain walking up stairs and uphill.Awaiting further investigations ct spect 2025 shows gutter impingement.(b)(6) 2025 on surgery waiting list.
Event or Problem Description
Subject: (b)(6).Uk infinity® total ankle system study.Pain and reduced mobility right ankle.Narrative of adverse event: at clinic (b)(6) 2024 patien reported 3 month history of pain walking up stairs and uphill.Awaiting further investigations ct spect 2025 shows gutter impingement.(b)(6) 2025 on surgery waiting list.Additional information received on 24 march 2026: adverse event term: "gutter impingement causing pain.Narrative additional comments: pla is for debridement of gutters, exchange poyethylene and capsular debridement.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY TIBIAL TRAY SIZE 3 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 ; 2018315000
• MDR Report Key: 24494281
• Report Number: 3010667733-2026-00168
• Device Sequence Number: 13430871
• Product Code: HSN
• UDI-Device Identifier: 00840420122506
• UDI-Public: (01)00840420122506(11)181219(17)261217(10)1641818
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140749
• 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,Followup
• Report Date (Section B): 04/14/2026

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: 33650003
• Device Lot Number: 1641818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2018
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 87 KG