MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680003
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Implant subsidence (4078)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event	11/10/2025
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 fractured the tibia and the tibia component is now displaced dorsally and involving the tibia anterior and may require a revision surgery.
Additional Manufacturer Narrative
Correction - h6 (device code).The reported event could be confirmed since the provided ct scan images show subsidence of the tibial component and the presence of a periprosthetic fracture.Upon further investigation of the ct scans by healthcare professionals the following was observed: the tibial component is subsided clearly and led to some impression of the anterior tibial cortex being regarded as a periprosthetic fracture, which can be confirmed, there is also a little radiolucence adjacent to the talus, but no clear loosening can be confirmed.The underlying cause seems to be mainly patient related due to poor bone substance.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.Although the issue is most likely patient related, the root cause could not be conclusively determined.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any 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 fractured the tibia and the tibia component is now displaced dorsally and involving the tibia anterior and may require a revision surgery.

• Brand Name: INFINITY ADAPTIS TIB SZ3 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: 23758447
• Report Number: 3010667733-2025-01476
• Device Sequence Number: 21355103
• Product Code: HSN
• UDI-Device Identifier: 00889797069656
• UDI-Public: (01)00889797069656(11)250303(17)330303(10)1812427
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/19/2026

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: 33680003
• Device Lot Number: 1812427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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