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

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of surgical revision cannot be conclusively determined; however, it is most likely due to patient related conditions; meaning that the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.

Event Description

It was reported via legal that a male patient had a right total ankle replacement in (b)(6) 2022 the patient underwent a revision surgery for an alleged ¿premature failure¿ of the ankle.The patient started having issues with the right ankle in (b)(6) 2022.No additional information available.

• Brand Name: VANTAGE ANKLE COMPONENTS
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15736213
• MDR Text Key: 303090143
• Report Number: 1038671-2022-01408
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2022

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: 10/27/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: No
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male