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

Model Number	TIBIAL PLATE FB SZ 4 LT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech vantage total ankle study, approximately 2.5 years post initial left taa, the 72 y/o male patient returned for pain below taa.The surgeon determined there is irregularity in the subtalar joint.Patient was given injection steroid into subtalar joint.Then, on (b)(6) 2023, follow-up from his sinus tarsi injection on the left ankle.The patient states that he did not get any relief even temporarily with the shot.The patient is mostly tender over the posterior tibial tendon.Referral to another surgeon for consideration of opening debridement and fdl tendon transfer.On (b)(6) 2023, the patient was there for follow-up.Patient has tried pt/hep.Pain worsening.Isolated to the posteromedial ankle.Has left posterior tibial tendinitis/partial tearing in the setting of prior taa.The event was resolved with patient having a revision on (b)(6) 2024.Per clinical report, the reported event is definitely not related to the device but possibly related to the procedure.
Additional Manufacturer Narrative
Section d10: concomitant products: tibial insert fb sz 2 lt 12mm (cat# 350-21-62 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b5, d4 (remove all data from initial report - catalog number unknown) d6b (remove date), g4, h4 (remove date) h6: clinical code, impact code, component code, type of investigation, investigation findings and investigation conclusions.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported by the exactech vantage total ankle study, approximately 2.5 years post initial left taa, the male patient returned for pain below taa.The surgeon determined there is irregularity in the subtalar joint.Patient was given injection steroid into subtalar joint.Then a follow-up from his sinus tarsi injection on the left ankle.The patient states that he did not get any relief even temporarily with the shot.The patient is mostly tender over the posterior tibial tendon.Referral to another surgeon for consideration of opening debridement and fdl tendon transfer.The patient was there for follow-up.Patient has tried pt/hep.Pain worsening.Isolated to the posteromedial ankle.Has left posterior tibial tendinitis/partial tearing in the setting of prior taa.The event was resolved with patient having a revision.Per clinical report, the reported event is definitely not related to the device but possibly related to the procedure.

• Brand Name: VANTAGE TOTAL ANKLE SYSTEM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18990537
• Report Number: 1038671-2024-00684
• Device Sequence Number: 7605151
• 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: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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 Model Number: TIBIAL PLATE FB SZ 4 LT
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2020
• 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: ANKLE SZ 4 LOCKING CLIP.; TALAR IMPLANT SZ 2 LT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White