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

Catalog Number 350-02-02

Device Problem Defective Device (2588)

Patient Problem Implant Pain (4561)

Event Date 11/01/2023

Event Type  Injury  

Event Description

It was reported via clinical study, that approximately 6 years postop the initial implant, this 63 year old male patient was revised due to a painful right total ankle arthroplasty with evidence of progressive osteolytic bone cysts around the tibial component and medial malleolus.The patient¿s outcome was last known as resolved.Devices will not be returned.

Manufacturer Narrative

D10.Concomitants: serial number item number and full description: (b)(6), 350-12-04 - tibial plate fb sz 4 rt.(b)(6), 350-22-42 - tibial insert fb sz 2 rt 10mm.

• 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: 17595618
• MDR Text Key: 321643201
• Report Number: 1038671-2023-02004
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276742
• UDI-Public: 10885862276742
• 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: 08/22/2023

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: 350-02-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White