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

Model Number	561-0010
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a femoral sleeve construct was revised.The bolt appeared to be loose at the time of revision.
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 from lack of support in the femoral bone.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: 17958126
• Report Number: 1722511-2023-00022
• Device Sequence Number: 17398572
• Product Code: JWH
• UDI-Device Identifier: 00822409037797
• UDI-Public: (01)00822409037797(17)231207(10)A206164
• 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: 2019
• Device Explanted Year: 2023
• 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): 09/29/2023

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 Expiration Date: 12/07/2023
• Device Model Number: 561-0010
• Device Lot Number: A206164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2018
• 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: 62 YR
• Patient Sex: Female