MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TALAR DOME SZ 1 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33630021
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	11/01/2025
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
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to the talus is causing the patient a lot of pain and appears to be loosening.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to the talus is causing the patient a lot of pain and appears to be loosening.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the returned image for evaluation don't matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: there is no clear loosening visible for both the tibia and the talus.The talus, however, seems to be lateralized and have a conflict with the fibula.The medial part looks a little distanced from the medial malleolus.It could be that there is loosening (although not be visible in the ct scan) and that led to the problem.A comparison with pre-existing x-ray or ct scan would be necessary to prove this.I would assume, that the problem is related to both the patient and poor bone substance, but also to a lateral positioning of the implant and therefore a treatment related issue.Failure of total ankle replacement tar over time is a known complication.In case of a planned revision procedure a medical opinion aiming to determine the root cause of the failure is part of the internal investigation process.Sufficient radiological and clinical information must be provided to enable a meaningful clinical assessment and to identify possible causes of failure.In cases where a ct scan is the only available clinical source, this assessment is limited.No conclusive statement can be provided, because key clinical information e.G., clinical status, exact symptoms, and range of motion of the patient, assessment of the treating physician is missing.The root causes of radiographic findings such as radiolucent areas and bone cysts are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and or the device in relation to cause of the failure.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.Although the issue is most likely related to patient condition or treatment, the root cause could not be conclusively determined.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY TALAR DOME SZ 1 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: 23831951
• Report Number: 3010667733-2025-01536
• Device Sequence Number: 13019378
• Product Code: HSN
• UDI-Device Identifier: 00840420122025
• UDI-Public: (01)00840420122025(11)180828(17)260826(10)1634357
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/26/2026
• Device Catalogue Number: 33630021
• Device Lot Number: 1770147
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2018
• 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: Other
• Patient Sex: Unknown