MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680014
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/05/2025
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 aseptic loosening of the tibial component.
Additional Manufacturer Narrative
The complaint could be confirmed, as the information provided for evaluation is consistent with the alleged failure.Upon further investigation of the ct scans by healthcare professionals, the following was observed.Loosening of the tibial component can be confirmed based on the provided images.Aseptic loosening is likely; however, the underlying cause remains unclear and may be patient-related due to poor bone quality.No specific abnormalities were identified.Failure of a total ankle replacement (tar) over time is a known complication.In the case of 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.When 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 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 critical information.Due to these limitations, statements regarding the patient, the procedure, or the device in relation to the cause of failure cannot be provided.A review of the device history for the reported lot did not identify any abnormalities.No corrective actions are required at this time.A review of the labeling did not identify any abnormalities.No indications of material-related, manufacturing-related, or design-related issues were identified during the investigation.Although the issue is most likely related to the patient¿s condition, the root cause could not be conclusively determined.More detailed information regarding the complaint event is required in order to determine the root cause of the complaint event.If the device is returned or if additional information is provided, the investigation will be reassessed.
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 of the tibial component.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG 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: 23713997
• Report Number: 3010667733-2025-01457
• Device Sequence Number: 18388129
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: (01)00889797069694(11)241024(17)321024(10)1801723
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• 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): 03/24/2026

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: 33680014
• Device Lot Number: 1801723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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: Male