MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 3 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33683308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject: 200-041.Infinity¿ with adaptis¿ total ankle replacement follow-up (itar2).(b)(6) 2024: patient reported persistent pain and swelling.No further informat.(b)(6) 2024: patient reported pain was worsening.Ae upgraded to sae and patient had the following procedures performed: tarsal tunnel release; right tenosynovectomy flexor hallucis longus right; excision medial talus and calcaneus osteophyte right; bone graft medial malleolar cyst and debridement, medial ankle joint.(b)(6) 2024: patient improving post-op but still experiencing ongoing persistent pain in subtalar joint.Steroid injection administered.(b)(6) 2025: most recent update states patient reports no change and still having pain in ankle joint area.Another steroid injection was administered.
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.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were 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.
Event or Problem Description
Subject: (b)(4).Infinity¿ with adaptis¿ total ankle replacement follow-up (itar2).(b)(6) 2024: patient reported persistent pain and swelling.No further informat (b)(6) 2024: patient reported pain was worsening.Ae upgraded to sae and patient had the following procedures performed: tarsal tunnel release; right tenosynovectomy flexor hallucis longus right; excision medial talus and calcaneus osteophyte right; bone graft medial malleolar cyst and debridement, medial ankle joint.(see attached operative notes) (b)(6) 2024: patient improving post-op but still experiencing ongoing persistent pain in subtalar joint.Steroid injection administered.(b)(6) 2025: most recent update states patient reports no change and still having pain in ankle joint area.Another steroid injection was administered.

• Brand Name: INFINITY EVERLAST SZ 3 8MM 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: 23536049
• Report Number: 3010667733-2025-01336
• Device Sequence Number: 15994386
• Product Code: HSN
• UDI-Device Identifier: 00889797074520
• UDI-Public: (01)00889797074520(11)210423(17)290421(10)1707173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 33683308
• Device Lot Number: 1707173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2021
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 83 KG