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

Catalog Number	350-12-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); Joint Impingement (4834)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 350-22-11 - tibial insert fb sz 1 rt 7mm.350-02-01 - talar implant sz 1 rt.
Event or Problem Description
As reported by the exactech vantage total ankle study, approximately 6 months post-op of initial implantation of a right tka, patient presented with impingement and pain.Medial gutter impingement and sural nerve entrapment, requiring secondary procedure.The outcome of the event was resolved by neuroplasty (of sural nerve) and ankle debridement approximately 4 months after reported event.The clinical report indicates that the event is definitely not related to the device(s) and definitely related 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/or corrected information.The following sections were updated: h6, h11 the following sections were corrected: d1, d4, d10, g4, h6.D10: 350-12-01 - tibial plate fb sz 1 rt 350-22-11 - tibial insert fb sz 1 rt 7mm 350-02-01 - talar implant sz 1 rt.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 review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from impingement and sural nerve entrapment, as stated in the information reported.However, this cannot be confirmed and potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information 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 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19515007
• Report Number: 1038671-2024-01901
• Device Sequence Number: 15273746
• Product Code: HSN
• UDI-Device Identifier: 10885862276179
• UDI-Public: 10885862276179
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 350-12-01
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 03/12/2026
• 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 H11; SEE H11
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White