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

Model Number	561-0510
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a total knee replacement was performed.In an x-ray dated (b)(6) 2023, an anterior femur fracture was detected and it appears that the junction box of the femoral sleeve construct is loose.A revision is planned but has not yet occurred.This report is being submitted because a proposed intervention was mentioned even though it has not yet occurred.
Additional Manufacturer Narrative
A dhr review identified no issues that could have caused or contributed to the reported event.It is believed that the junction box loosened due to fatigue loading in the knee.The available evidence does not lead to a clear conclusion about the cause of the reported event.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• Common Device Name: 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: 16620149
• Report Number: 1722511-2023-00006
• Device Sequence Number: 6193774
• Product Code: MBH
• UDI-Device Identifier: 00822409037827
• UDI-Public: (01)00822409037827(17)270309(10)A233348
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K181569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: 561-0510
• Device Lot Number: A233348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male