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

Catalog Number	350-22-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 350-12-01 - tibial plate fb sz 1 rt.350-02-02 - talar implant sz 2 rt.350-10-01 - ankle sz 1 locking clip.(h3) pending evaluation.
Event or Problem Description
As reported by the exactech vantage total ankle study, the 64-year-old female patient had an initial right taa on (b)(6) 2018 captured on (b)(4) with a revision to the ankle (b)(6) 2022.The patient presented with pain, 1 year(s) and 3 month(s) post procedure on (b)(6) 2023.The patient reports traveling through the (b)(6) in (b)(6) approximately 4 weeks ago.Developed increased pain and swelling in the right ankle.Patient denies known injury or trauma and reports the pains are primarily along the outside of the ankle, but also has some pain in the front and inside of the ankle.The outcome of this event is considered continuing and the report indicates that the action taken is other - anti-inflammatory meds - prn, recommend walking boot to provide support.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d10, h6, h11 the following sections were corrected: d1, d4, g4, h6 d10: (b)(6) - tibial plate fb sz 1 rt (b)(6) - talar implant sz 2 rt (b)(6) - ankle sz 1 locking clip (b)(6) - tibial insert fb sz 2 rt 6mm h11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined; however, cannot be conclusively determined.The activity reported by the patient may have contributed to the reported event however this and the reported event cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, and radiographs were not provided.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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18876978
• Report Number: 1038671-2024-00452
• Device Sequence Number: 15715823
• Product Code: HSN
• UDI-Device Identifier: 10885862276346
• UDI-Public: 10885862276346
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 350-22-02
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White