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

Model Number	350-22-44
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right ankle replacement on (b)(6) 2020.The patient complained of pain and had a recalled implant so was revised to competitor devices on (b)(6) 2023.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: 350-02-04 - talar implant sz 4 rt 6521287, 350-10-04 - ankle sz 4 locking clip 6404301, 350-12-04 - tibial plate fb sz 4 rt 6291544, 350-02-04 - talar implant sz 4 rt 6521287, 351-90-20 - tubercle pin pouch 6406846, 351-90-21 - 3.5" pin pouch 6372675, 351-90-22 - 2.5" pin pouch 6411117, and 351-90-24 - talar trial screw pouch 6535040.

• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17094826
• Report Number: 1038671-2023-01297
• Device Sequence Number: 16611432
• Product Code: HSN
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 350-22-44
• Device Catalogue Number: 350-22-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male