MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL COMPONENT

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, approximately 15 months postop, this male (b)(6) thin, healthy male, fractured his r ankle cage 15 months postop and was revised.No other information is available at this time.

Manufacturer Narrative

Section h10: d6b: (b)(6) 2021.H3: the revision reported may have been the result of an insufficient bond between the tibial component and the bone, which led to aseptic (non-infected) tibial loosening and ultimately resulted in the fracturing of the center cage.However, this cannot be confirmed as device was not available for evaluation.

• Brand Name: VANTAGE
• Type of Device: TIBIAL COMPONENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12126896
• MDR Text Key: 260258879
• Report Number: 1038671-2021-00324
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR