MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient has fallen into varus and the physician would like to revise the tar.
Event or Problem Description
It was reported that the patient has fallen into varus and the physician would like to revise the tar.
Additional Manufacturer Narrative
The reported event could not be confirmed, as the affected device was not returned and no supporting evidence was provided.Device inspection could not be performed because the product was not returned for investigation.A review of the device history records for the reported lot did not identify any abnormalities.No corrective actions are required at this time.A review of the product labeling did not identify any abnormalities.No indications of material, manufacturing, or design-related issues were identified during the investigation.Failure of total ankle replacement (tar) over time is a known complication.In cases involving a planned revision procedure, a medical assessment aimed at determining the root cause of failure is part of the internal investigation process.Adequate radiological and clinical information must be provided to enable a meaningful clinical evaluation and to identify potential causes of failure.When a ct scan is the only available clinical information, the assessment remains limited.No conclusive determination can be made due to the absence of key clinical information, including patient clinical status, specific symptoms, range of motion, and evaluation by the treating physician.The root causes of radiographic findings, such as radiolucent areas and bone cysts, are often complex and multifactorial and cannot be scientifically determined without sufficient supporting evidence.Due to these limitations, no conclusions can be drawn regarding the patient, the procedure, or the device in relation to the cause of failure.Additional detailed information regarding the complaint event and the affected device is required to determine the root cause.If the device is returned or additional information becomes available, the investigation will be reassessed.

• Brand Name: INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS
• 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: 24744526
• Report Number: 3010667733-2026-00279
• Device Sequence Number: 21176433
• Product Code: HSN
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 33680013
• Device Lot Number: 1785581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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: Unknown