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	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been 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 tibial component loosening.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was not returned for evaluation and but with available radiograph alleged event can be confirmed.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.Based on available ct scans a formal medical opinion was sought the ct scan shows significant cysts and also a clear subsidence/migration of the tibial component posteriorly.There is some radiolucence adjacent to the talar component, but no clear subsidence or loosening can be seen, here.There is no obvious reason for the loosening, therefore poor bone substance and thus a patient related cause is likely.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.Based on the formal opinion from the available ct scans, the root cause is most likely patient related due to poor bone substance.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a revision surgery due to tibial component loosening, poly removed with loosened tibia and the talus was removed for new tibial component placement and approach.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20679624
• Report Number: 3010667733-2024-00867
• Device Sequence Number: 21007746
• Product Code: HSN
• UDI-Device Identifier: 00889797069663
• UDI-Public: 00889797069663
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 1767272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2023
• 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; Required Intervention
• Patient Sex: Male