MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE REVISION SYSTEM; JUNCTION BOX

Model Number	561-0510
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2022, a patient received a total knee replacement.On (b)(6) 2023, the patient was revised for tibial loosening.In (b)(6) 2024, the patient was revised again for tibial loosening.During the latest revision, the femoral component was discovered to be loose as well and the t-nut from the junction box was removed with it.The taperlock portion of the junction box was well-fixed to the femoral sleeve.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• Common Device Name: JUNCTION BOX
• 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: 20793176
• Report Number: 1722511-2024-00016
• Device Sequence Number: 6754711
• Product Code: JWH
• UDI-Device Identifier: 00822409037827
• UDI-Public: (01)00822409037827(17)290210(10)A264890
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: A264890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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: 67 YR
• Patient Sex: Male