MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE REVISION SYSTEM; STEM EXTENSION

Model Number	565-1405
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and showed the device was manufactured according to the specification.There is not enough information to determine the root cause of this incident with certainty.The stem fractured with the threads remaining in the t-nut of the junction box.The stem thread fracture appears to have been exacerbated by increased forces across the stem and junction box likely caused from malalignment of the implants, improper assembly/tightening of the implants, or patient related factors.This is report 2 of 2.Report 1 was originally submitted listing the junction box as the part number in d4.However, upon completing the evaluation, a stem thread fracture was discovered as the main issue so this second report is being submitted for the stem.
Event or Problem Description
On (b)(6) 2023, an x-ray showed a dislodged component from the original surgery and an anterior femoral fracture which meant the junction box and stem had migrated.X-rays from original surgery have not been provided.A revision was performed on (b)(6) 2023.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• Common Device Name: STEM EXTENSION
• 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: 21378776
• Report Number: 1722511-2025-00004
• Device Sequence Number: 3849168
• Product Code: JWH
• UDI-Device Identifier: 00822409004935
• UDI-Public: (01)00822409004935(17)230208(10)A189611
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K031201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 02/07/2023

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: 02/08/2023
• Device Model Number: 565-1405
• Device Lot Number: A189611
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2018
• 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: 78 YR
• Patient Sex: Male