MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE FIXED-BEARING ANKLE COMPONENTS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech vantage total ankle study, the 62 year old female patient had an initial left taa on (b)(6) 2022 and presented with lucency and cyst formation approximately 1 year post initial procedure on (b)(6) 2023.On (b)(6) 2023, the subject's radiographic findings determined there is increased lucency about the tibial component compared to (b)(6) 2023.Subject came in for a follow-up visit pertaining to the findings on (b)(6) 2024.On (b)(6) 2024, radiographic findings stated that there was stable lucency about the tibial component compared to (b)(6) 2023, but increased since (b)(6) 2023.The case report form indicates that this event is unlikely related to the device and definitely not related to the procedure.The report also indicates the action taken was medication and the outcome of this event is continuing.350-11-01 - tibial plate fb sz 1 lt: 6694220.No device return anticipated due to being a clinical trial study.
Additional Manufacturer Narrative
(d10) concomitant device(s): 350-21-21 - tibial insert fb sz 1 lt 8mm: 5299361, 350-10-01 - ankle sz 1 locking clip: 7041185, 350-01-01 - talar implant sz 1 lt 6860302, 351-91-03 - recip sawblade 8x50x1mm: 038799.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b2, b5, d1, d4 (remove all data from initial report - catalog number-unknown) g1, g4, h4 (remove date) clinical code, impact code, component code, type of investigation, investigation findings and investigation conclusions.The reason for the event reported may have been due to bone cyst formation, as stated in the information reported.However, this cannot be confirmed and potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported by the exactech vantage total ankle study, the female patient had an initial left taa and presented with lucency and cyst formation approxiamtely one year post initial procedure.The subject's radiographic findings determined there is increased lucency about the tibial component compared to previous results.Subject came in for a follow-pp visit pertaining to the findings.The radiographic findings stated that there was stable lucency about the tibial component compared to previous results but has increased.The action taken was medication and the outcome of this event is continuing.

• Brand Name: VANTAGE FIXED-BEARING ANKLE COMPONENTS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18620233
• Report Number: 1038671-2024-00144
• Device Sequence Number: 11372840
• Product Code: HSN
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White