MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/05/2026
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
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to persistent pain.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to persistent pain.
Additional Manufacturer Narrative
The reported event could not be confirmed, as radiolucency and potential loosening are visible for both components.However, no clear loosening is definitively visible in either the talar or tibial components.Device inspection was not possible because the product was not returned for investigation.A review of the device history record for the reported lot did not indicate any abnormalities.Therefore, no corrective actions are required at this time.A review of the labeling did not identify any abnormalities.No indications of material-, manufacturing-, or design-related issues were identified during the investigation.Further evaluation of the ct scans by healthcare professionals indicated the presence of radiolucency and potential loosening in both components.However, no clear loosening is definitively visible in either the talus or the tibia.The tibial component shows some anterior elevation and areas of condensed bone.The reporting site suspects that the talar component may be loosened; however, based on the available imaging, loosening could involve either component.The underlying cause of any potential loosening that may be identified intraoperatively is unclear but could be related to patient-related factors, such as poor bone quality.Failure of a total ankle replacement over time is a known complication.In cases where a revision procedure is planned, a medical opinion aimed at determining the root cause of the failure is part of the internal investigation process.Sufficient radiological and clinical information must be provided to allow a meaningful clinical assessment and identification of possible failure causes.When a ct scan is the only available clinical information, the assessment is limited.No conclusive statement can be made due to the absence of key clinical information, including the patient¿s clinical status, exact symptoms, range of motion, and the treating physician¿s assessment.The root causes of radiographic findings such as radiolucent areas and bone cysts are often complex and multifactorial and cannot be scientifically determined without this critical supporting information.Due to these limitations, no definitive statements can be made regarding the patient, the procedure, or the device in relation to the cause of failure.Based on the investigation, the issue most likely occurred due to patient-related factors, such as poor bone quality.However, more 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 TALDOME SZ2 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: 24184410
• Report Number: 3010667733-2026-00067
• Device Sequence Number: 10016552
• Product Code: HSN
• UDI-Device Identifier: 00889797101523
• UDI-Public: (01)00889797101523(11)220130(17)300128(10)1721419
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• 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): 04/09/2026

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: 33680022
• Device Lot Number: 1721419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2022
• 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