MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE STATURE® FEMUR; KNEE COMPONENT

Model Number KFTCXXXX

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Allegedly, eprd reported 210 cases, 7 complication (2 infection and 5 unknow).No further information was reported.No further information was reported on the matter.2 infection incidents: 24010001, 24010002 5 unknown failure incidents: 24010003, 24010004, 24010005, 24010006, 24010007.

• Brand Name: ADVANCE STATURE® FEMUR
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18587851
• MDR Text Key: 333849531
• Report Number: 3010536692-2024-00046
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KFTCXXXX
• Device Catalogue Number: KFTCXXXX
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention