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

Catalog Number	350-11-04
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Comcomitant medical products: category #: 350-21-03 - tibial insert fb sz 3 lt 6mm.Category #: 350-01-03 - talar implant sz 3 lt.
Event or Problem Description
It was reported via clinical study, that the 71 yo male patient is still experiencing discomfort in left ankle with sharp aching pain on the anteromedial aspect of ankle.The date of adverse event onset is (b)(6) 2021.The provider planned to do revision surgery to remove vantage and replace with inbone.The patient was revised on (b)(6) 2021.There was a previous surgery (debridement) on involved ankle (b)(6) 2014.The patient¿s outcome was last known as resolved.The case report form indicates this event is possibly related to device and possibly related to procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, g2 (initial report), h6: clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.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 if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: VANTAGE 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, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16561161
• Report Number: 1038671-2023-00456
• Device Sequence Number: 17517408
• Product Code: HSN
• UDI-Device Identifier: 10885862276162
• UDI-Public: 10885862276162
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Device Expiration Date: 04/23/2021
• Device Catalogue Number: 350-11-04
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2017
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White