MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680004
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that revision surgery may be required.A total ankle replacement with a wright medical/stryker device was previously performed for arthritis and ankle pain.Reports include swelling and medial ankle pain, with imaging suggesting a possible medial malleolus stress fracture and potential tibial tray loosening.No revision has been performed to date.Bone quality was described as good, and compliance with mobilization instructions was noted, though a physically active lifestyle may have contributed to the reported symptoms.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that revision surgery may be required.A total ankle replacement with a wright medical/stryker device was previously performed for arthritis and ankle pain.Reports include swelling and medial ankle pain, with imaging suggesting a possible medial malleolus stress fracture and potential tibial tray loosening.No revision has been performed to date.Bone quality was described as good, and compliance with mobilization instructions was noted, though a physically active lifestyle may have contributed to the reported symptoms.
Additional Manufacturer Narrative
Correction: h6 device code.The reported event was not confirmed for the talar component since the device was not returned for evaluation and no other evidences were provided.Upon further investigation of the ct scans by healthcare professionals the following was observed: the ct scan shows some radiolucence and some cysts tibially.There seems to be loosening and some subsidence at the anterior aspect of the device.Loosening and migration can be confirmed.There is no clear evidence of fracture of the medial malleolus.The bone status looks at least normal for an almost 50 y old woman.The talus does not show clear signs of loosening or migration.The hcp suspects a high level of activity and load as contributing factor for the loosening, which can not be excluded.The ct scan does not give an answer to the question what led to the failure.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.

• Brand Name: INFINITY ADAPTIS TIB SZ4 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: 23142671
• Report Number: 3010667733-2025-01097
• Device Sequence Number: 21044550
• Product Code: HSN
• UDI-Device Identifier: 00889797074605
• UDI-Public: (01)00889797074605(11)221130(17)301130(10)1736377
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 11/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680004
• Device Lot Number: 1736377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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: 48 YR
• Patient Sex: Female