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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 350-12-03 - tibial plate fb sz 3 rt.350-02-03 - talar implant sz 3 rt.
Event or Problem Description
It was reported via clinical study, that the 40 yo white male patient was experiencing pain along medial ankle when weightbearing, related to start up pain after initiating walking from seated position (pain 3 out of 10).The date of onset is (b)(6) 2019.The patient underwent revision surgery on (b)(6) 2020; vantage removed.Patient was withdrawn.The patient¿s outcome was last known as resolved on (b)(6) 2020.
Event or Problem Description
It was reported via clinical study, that the 40 yo white male patient was experiencing pain along medial ankle when weightbearing, related to start up pain after initiating walking from seated position (pain 3 out of 10).The date of onset is (b)(6) 2019.The patient underwent revision surgery on (b)(6) 2020; vantage removed.Patient was withdrawn.The patient¿s outcome was last known as resolved on (b)(6) 2020.The case report form indicates this event is possibly related to device and unlikely related to procedure.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the patient's condition cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported via clinical study, that the 40 yo white male patient was experiencing pain along medial ankle when weightbearing, related to start up pain after initiating walking from seated position (pain 3 out of 10).The date of onset is (b)(6) 2019.The patient underwent revision surgery on (b)(6) 2020; vantage removed.Patient was withdrawn.The patient¿s outcome was last known as resolved on (b)(6) 2020.The case report form indicates this event is possibly related to device and unlikely related to procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b1, b2, d4 (remove all data from initial report catalog number is unknown) h4 (remove date) h6: clinical code, component code, investigation findings.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: kate jacobson
• MDR Report Key: 16539249
• Report Number: 1038671-2023-00432
• Device Sequence Number: 12343579
• 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: 2018
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 01/15/2026

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: 02/15/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 01/14/2026
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 12/01/2023; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White