MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TALAR DOME SZ 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33630022
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/12/2025
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 aseptic loosening.
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient; therefore, an evaluation of the device cannot be performed.If additional information becomes available, it will be provided on 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 aseptic loosening.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the talar component shows little radiolucence and seems to show a little anterior dislocation of the component, but that can only be confirmed with postoperative x-rays or ct after the implantation.The device inspection was not possible as the product was not returned for investigation.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.Upon further investigation of the ct scans, healthcare professionals opined that- the ct scan shows clear radiolucence, anterior cysts and dislocation of the tibial component.Therefore, loosening and migration can be confirmed for the tibia.The talar component shows little radiolucence and seems to show a little anterior dislocation of the component, but that can only be confirmed with postoperative x-rays or ct after the implantation.The underlying cause of the failure is not clear but may be patient related due to poor bone substance.However, 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.Based on investigation the issue is caused most likely due to patient related factor i.E., poor bone substance but more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY TALAR DOME SZ 2 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: 22460668
• Report Number: 3010667733-2025-00801
• Device Sequence Number: 8826821
• Product Code: HSN
• UDI-Device Identifier: 00840420122032
• UDI-Public: (01)00840420122032(11)230811(17)310811(10)1764287
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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 Catalogue Number: 33630022
• Device Lot Number: 1764287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• 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: 65 YR
• Patient Sex: Female