MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 2 RT

Model Number 350-12-02

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

Patient Problem Failure of Implant (1924)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

The revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the devices were not available for evaluation.Concomitant device(s): 350-22-22, 4537226 - tibial insert fb sz 2 rt 8mm.350-10-02, 4565390 - ankle sz 2 locking clip.350-02-02, 4579058 - talar implant sz 2 rt.

Event Description

Approximately 1.5 years postop the initial right ankle implant, this female patient experienced tibial loosening and was revised.Patient is doing well now.Removal of vantage implant.No other information available as revision was completed out of the clinical study and no study id was available.Device is not returning.

• Brand Name: VANTAGE
• Type of Device: TIBIAL PLATE FB SZ 2 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 11330181
• MDR Text Key: 235012297
• Report Number: 1038671-2021-00045
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276186
• UDI-Public: 10885862276186
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 350-12-02
• Device Catalogue Number: 350-12-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2016
• 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): Hospitalization; Required Intervention