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

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	Cyst(s) (1800); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 350-12-03 fixed bearing tibial catalog ref.No, 350-22-22 fixed bearing liner catalog ref.No, 350-02-02 talar catalog ref.No, tibial locking clip catalog.
Event or Problem Description
It was reported via clinical study, that the 72 yo white male patient experienced increasing pain discomfort in right ankle, affecting gait.Ct scan shows large periprosthetic cystic lucencies adjacent to tibial tray.Severe posterior subtalar joint arthrosis.The date of onset is (b)(6) 2020.The patient underwent revision surgery on (b)(6) 2020.The patient¿s outcome was last known as resolved on (b)(6) 2020.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b1, b2, b3, b5, d1, d4 (remove all data from initial report - catalog number- unknown) g1, g4, h6: clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings and investigation conclusions.The cause of the patient¿s bone cysts and revision reported cannot be conclusively determined; however, it may be due to patient-related factors, a reaction to wear or debris particles, or component alignment.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported via clinical study, that the white male patient experienced increasing pain/discomfort in his right ankle, affecting gait.Ct scan shows large periprosthetic cystic lucencies adjacent to tibial tray.Severe posterior subtalar joint arthrosis.The patient underwent revision surgery.The patient¿s outcome was last known as resolved.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following section was corrected: h6: clinical code.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, 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: geoff gannon
• MDR Report Key: 16542144
• Report Number: 1038671-2023-00439
• Device Sequence Number: 17772375
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 02/15/2023
• Supplement Date Received by Manufacturer: 01/13/2026; 01/13/2026
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 01/14/2026; 01/14/2026
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White