MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INVISION TALAR DOME SIZE 4 STD; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	60012004
Medical Device Problem Codes	Osseointegration Problem (3003); Unintended Movement (3026)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery is needed due to talus component screws¿ breakage.The existing tibia component will remain in situ.It was also reported that the patient had: "no pain and excellent mobility for a year, followed by sudden onset of pain while walking with a feeling of breaking.Since then, pain when loading especially in the subtalar region." additionally: "revision history: no revision of the talus was performed but a first implant due to a large talar cyst.".
Additional Manufacturer Narrative
The reported event could be confirmed since images of ct scans were provided and shows loosening and subsidence of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: the ct scan here shows some radiolucence adjacent to the tibial component, but neither loosening nor breakage can be confirmed with the ct scan.The talar component seems to show some loosening and also looks a little subsided.There is poor bone stock below it with large cysts.There is also bone cement placed adjacent to the central part of the talar component.The described screw crosses this area, which shows, that there is active mobility in this area suggesting a loosening of the talar component.Based on investigation, the root cause could be attributed to a patient related issue.The failure of the talar component was most likely caused by poor bone stock.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: INVISION TALAR DOME SIZE 4 STD
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21894316
• Report Number: 3010667733-2025-00495
• Device Sequence Number: 8387644
• Product Code: HSN
• UDI-Device Identifier: 00840420193957
• UDI-Public: (01)00840420193957(11)220908(17)300908(10)1709940
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K171067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 60012004
• Device Lot Number: 1709940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 98 KG