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

Catalog Number	33630023
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient required a revision surgery "for pain and lucencies around the implant? infection.Done for post-traumatic arthritis, previous fracture/orif/rom.No obvious patient factors beyond being a little overweight.Bone quality was reasonably good - a few cystic areas as predicted.Activity level was restricted by ankle symptoms.I think the patient was compliant with instructions" the patient is currently implanted with a bone cement spacer.Imaging identified a posterior line fracture present in the tibia and radiopaque feature identified in the tibia bone (sclerotic bone).Additional feedback from the surgeon stated that "it would seem infection is not the issue causing loosening.It doesn't appear to be infection.".
Additional Manufacturer Narrative
The complaint could not be confirmed, indeed the product was returned for evaluation, but it does not matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that some foreign substances is visible at the coating, most likely it is ingrown bone.Otherwise, the implant is in a used but good condition, with some marks from use.Upon further investigation of the ct scans by healthcare professionals the following was observed: there is not too much to add, i would say.With all that we know it is not clear whether there was an infection or not-it could at least not be proved by microbiology or histology although it seemed very likely for the hcp.I assume, that the implant was loosened before it was taken out and there was the girdlestone-situation, but that cannot be said with clarity.There are two options now: either we say, that it is not clear with the given information or that it cannot be assessed at all due to lack of information.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 more information is provided, the case will be reassessed.

• Brand Name: INFINITY TALAR DOME SZ 3 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: 23831915
• Report Number: 3010667733-2025-01537
• Device Sequence Number: 15770014
• Product Code: HSN
• UDI-Device Identifier: 00840420122049
• UDI-Public: (01)00840420122049(11)230308(17)310308(10)1745972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123954
• 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
• Report Date (Section B): 12/17/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33630023
• Device Lot Number: 1745972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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: Required Intervention
• Patient Sex: Unknown