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

Catalog Number 350-01-02

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: (b)(6), 350-10-04 - ankle sz 4 locking clip; (b)(6), 350-11-04 - tibial plate fb sz 4 lt; (b)(6), 350-21-12 - tibial insert fb sz 2 lt 7mm; ***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6), 351-90-20 - tubercle pin pouch; (b)(6), 351-90-21 - 3.5" pin pouch; (b)(6), 351-90-22 - 2.5" pin pouch.

Event Description

It was reported via clinical study, that approximately 3 years postop the initial implant, this 69 yo male patient had increasing discomfort and pain located over the subtalar joint, ankle joint, and anteromedial distal tibia.Pain is so severe that patient uses boot to ambulate.Imaging demonstrates flattening of the talar dome and mild subsidence of the talar hardware and multifocal periprosthetic osteolysis along the tibial hardware-bone interface measuring up to 2.1 cm.Patient was revised to left ankle arthroplasty with inbone-ii prosthesis.The patient¿s outcome was last known as resolved.Devices will not be returned.

• Brand Name: VANTAGE
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson
• MDR Report Key: 17484818
• MDR Text Key: 320668968
• Report Number: 1038671-2023-01912
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276704
• UDI-Public: 10885862276704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 350-01-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White