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

Model Number	TIBIAL INSERT FB SZ 2 RT 7MM
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); Ambulation or Postural Difficulties (2544)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical studies, exactech vantage total ankle study, that a 57 yo male patient, who had an initial ankle implanted on (b)(6) 2017, reported pain along the medial aspect of the ankle and the later aspect of the ankle, just in the sub-fibular area, along the posterior tibial tendon, and he reported difficulty walking.Date of adverse event onset, (b)(6) 2022.He was given a supinator brace and a corticosteroid shot into the subtalar joint.Unlikely related to device and is definitely not related to procedure.Outcome indicates continuing.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 pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
No device return anticipated as it remains implanted.Concomitants medical devices: 350-12-04 tibial plate fb sz 4 rt, 350-02-02 talar implant sz 2 rt, 350-10-04 ankle sz 4 locking clip.
Additional Manufacturer Narrative
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 pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from initial report-suspect product unknown), g4 (remove 501k from initial report-unknown), h6: clinical codes, medical device problem code, component code, investigation type, findings and conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: VANTAGE ANKLE SYSTEM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15385691
• Report Number: 1038671-2022-01065
• Device Sequence Number: 5809800
• Product Code: HSN
• UDI-Device Identifier: 10885862276384
• UDI-Public: 10885862276384
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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 INSERT FB SZ 2 RT 7MM
• Device Catalogue Number: 350-22-12
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White