MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 3+ 9MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33684309
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stryker prophecy team has received a ct scan for upcoming revision surgery, however, the reason for the revision is still unknown.At this time, it cannot be determined which of the devices involved may have caused or contributed to the reported event.Therefore, the 4143377 will be filed as an mdr, and the rest of the devices involved will be referenced in section h11 of an mdr.Additional information was requested from the initial reporter and if becomes available the reportability decision will be reevaluated.Also, once the investigations are completed the information will be reevaluated to determine if additional mdrs are required at that time.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery for reasons unknown.
Additional Manufacturer Narrative
The complaint was not confirmed, since the returned image for evaluation don't matches the alleged 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.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.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 may require a revision surgery for reasons unknown.

• Brand Name: INFINITY EVERLAST SZ 3+ 9MM 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: 23550239
• Report Number: 3010667733-2025-01347
• Device Sequence Number: 13205299
• Product Code: HSN
• UDI-Device Identifier: 00889797074568
• UDI-Public: (01)00889797074568(11)220617(17)300617(10)1735075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• 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): 12/30/2025

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: 33684309
• Device Lot Number: 1735075
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2022
• 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 Sex: Male