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

Catalog Number	33680031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to pain and discomfort of ankle.
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 pain and discomfort of ankle.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.Upon further investigation of the ct scans by healthcare professionals, the following was observed: the construct is intact, well-fixed, and well-positioned, with no obvious reason for revision visible.Failure of total ankle replacement (tar) over time is a known complication.In cases involving a planned revision procedure, 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 enable a meaningful clinical assessment and to identify possible causes of failure.Where a ct scan is the only available clinical source, this assessment is limited.No conclusive statement can be provided because key clinical information, such as the patient¿s clinical status, exact symptoms, range of motion, and the treating physician¿s assessment, is missing.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 decisive evidence.Due to these limitations, we are unable to provide statements regarding the patient, the procedure, or the device in relation to the cause of the failure.More detailed information about the complaint event and the affected device is required to determine the root cause of the complaint.A review of the device history record 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 identified during the investigation.If the device is returned or additional information becomes available, the investigation will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 1 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: 24513110
• Report Number: 3010667733-2026-00178
• Device Sequence Number: 10227187
• Product Code: HSN
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 33680031
• Device Lot Number: 1682876
• 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): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2020
• 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 Age: 53 YR
• Patient Sex: Female