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

Catalog Number 350-12-03

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported via clinical study, that the 78 yo male patient had x-rays that showed a progression of tibial component subsidence into the anterior tibia and a suggestion of loosening of tibial component.The date of adverse event onset is (b)(6) 2020.The provider recommended revision to implant with stemmed tibial component.Patient was revised on (b)(6) 2021 with exactech components.The patient¿s outcome was last known as resolved.

Manufacturer Narrative

Concomitant medical product(s): serial #: (b)(4), category #: 350-22-63 - tibial insert fb sz 3 rt 12mm, the serial number (b)(4) is not affected by the recall.Serial #: (b)(4), category #: 350-02-03 - talar implant sz 3 rt, serial #: (b)(4), category #: 350-10-03 - ankle sz 3 locking clip.

• Brand Name: VANTAGE
• Type of Device: 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16560010
• MDR Text Key: 311481736
• Report Number: 1038671-2023-00454
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• 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: 03/16/2023

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: 350-12-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White