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

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	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient had bilateral knee revision surgery on (b)(6) 2024.On (b)(6) 2025, the left knee was revised again.The current status of the right knee is unknown, the surgeon noted that both taper locks (femoral and tibial sleeve assemblies) of the left knee were loose.The explanted implants were discarded at the hospital.This is report 1 of 2 for the femoral side of this surgery.The original modular femoral component, tapered junction box, locking bolt, and femoral augments were loose at the taper and thus explanted and discarded.The surgeon opted to leave the original femoral sleeve and stem in-situ as they were well-fixed.A new tapered junction box with locking bolt along with a new modular femoral component were assembled using instrumentation from another company.The femoral and tapered junction box assembly was impacted into the original femoral sleeve taper that was still in the femur from the original surgery.The removed femoral component was size 5l with 2 posterior augments.It was replaced with a new size 5l femoral component with no augments.

• Brand Name: BALANCED KNEE SYSTEM REVISION
• 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: 24172922
• Report Number: 1722511-2026-00003
• Device Sequence Number: 9569695
• Product Code: MBH
• UDI-Device Identifier: 00822409037827
• UDI-Public: (01)00822409037827(17)311003(10)A404286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: A404286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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: 69 YR
• Patient Sex: Female