MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SZ 4 LNG TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33650014
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	12/08/2025
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 worsening pain after being monitored for cystic changes for over 1 year.The loosening of the implants has progressed.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to worsening pain after being monitored for cystic changes for over 1 year.The loosening of the implants has progressed.
Additional Manufacturer Narrative
The reported event could be confirmed, as ct scan images were provided and demonstrated loosening of both the tibial and talar components.Upon further review of the ct scans by healthcare professionals, loosening of both components was confirmed.Radiolucent areas and cysts were observed adjacent to the tibial and talar components.The radiolucency associated with the talar component was primarily anterior.The underlying cause of the failure was not identified, and no obvious cause was visible on imaging.Failure of total ankle replacement (tar) 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 is required to enable a meaningful clinical assessment and to identify potential causes of failure.When a ct scan is the only available clinical source, the assessment is limited.No conclusive statement can be provided due to the absence of key clinical information, including the patient¿s clinical status, specific 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 determined scientifically without this critical information.Due to these limitations, no statements can be made regarding the patient, the procedure, or the device in relation to the cause of failure.More detailed information regarding the complaint event and the affected device is required to determine the root cause of the reported event.A review of the device history for the reported lot did not identify any abnormalities, and no corrective actions are required at this time.A review of the labeling also did not identify any abnormalities.No indications of material, manufacturing, or design-related issues were identified during the investigation.If the device is returned or if additional information becomes available, the investigation will be reassessed.

• Brand Name: INFINITY TIBIAL TRAY SZ 4 LNG 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: 23968586
• Report Number: 3010667733-2026-00013
• Device Sequence Number: 9343100
• Product Code: HSN
• UDI-Device Identifier: 00840420122551
• UDI-Public: (01)00840420122551(11)190130(17)270128(10)1645185
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• 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): 03/19/2026

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: 33650014
• Device Lot Number: 1645185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2019
• 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: Female