MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE REVISION SYSTEM; TOTAL KNEE PROSTHESIS

Model Number 561-0510

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

Patient Problem Arthralgia (2355)

Event Type  Injury  

Manufacturer Narrative

No specific dates were provided in this report.No patient information nor lot information was provided in this report.

Event Description

Approximately 2 years after a total knee replacement, a patient presented with increased knee pain.The x-ray shows a fracture of the anterior portion of the femur.The femoral sleeve and junction box are well fixed in the same location but the femoral component has translated anterior since the original implantation.It is anticipated that the femoral component is loose at the junction box rails.A revision has been considered but there are no plans to perform one yet.This report is being submitted out of an abundance of caution because a proposed intervention was mentioned even though it has not yet occurred.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• Type of Device: TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 16628574
• MDR Text Key: 312136431
• Report Number: 1722511-2023-00008
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 561-0510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2023
• 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