MAUDE Adverse Event Report: PARAGON 28, INC APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369); Fluid Discharge (2686)

Event Date 08/03/2022

Event Type  Injury  

Event Description

8 months post a total ankle replacement with apex items a radiograph showed a stress fracture in the medial and lateral malleolus.The subject reported an increase in activity of walking while moving houses prior to the fracture.At 10 months post total ankle replacement a surgery was conducted to treat the stress fractures with hardware implantation and bone allografts.3 weeks later the subject presented with an infection of the recent surgical site with discharge.

• Brand Name: APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 16822647
• MDR Text Key: 314080497
• Report Number: 3008650117-2023-00090
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/27/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 101 KG