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

Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377); Implant Pain (4561)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that approximately 6 years postop the initial implant, this 63 year old male patient was revised due to a painful right total ankle arthroplasty with evidence of progressive osteolytic bone cysts around the tibial component and medial malleolus.The patient¿s outcome was last known as resolved.Devices will not be returned.
Additional Manufacturer Narrative
D10.Concomitants: serial number item number and full description: (b)(6), 350-12-04 - tibial plate fb sz 4 rt.(b)(6), 350-22-42 - tibial insert fb sz 2 rt 10mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b1, b2, b3, d1, d4 (remove all data from initial report - catalog number- unknown) g1, g4, h4 (remove date) h6: clinical code, medical device problem code, component code, type of investigation, investigation findings and investigation conclusions.The reason for the revision 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.

• Brand Name: VANTAGE FIXED-BEARING ANKLE COMPONENTS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17595618
• Report Number: 1038671-2023-02004
• Device Sequence Number: 7402595
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,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?: Yes
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White