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

Model Number	561-5000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
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 likely means the junction box and stem have migrated.X-rays from original surgery have not been provided.No revision surgery has been reported.This report is being submitted out of an abundance of caution because a proposed intervention may be performed even though it has not yet occurred.
Event or Problem Description
On (b)(6) 2023, the patient in the initial report was revised.
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.The junction box was listed as the part number in d4 for this report.However, upon completing the evaluation, a stem thread fracture was discovered as the main issue so a second report for the stem is being submitted for this incident.

• 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: 17561432
• Report Number: 1722511-2023-00020
• Device Sequence Number: 20553085
• Product Code: JWH
• UDI-Device Identifier: 00822409004140
• UDI-Public: (01)00822409004140(17)250905(10)A201281
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K060569
• 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,Followup,Followup
• Report Date (Section B): 07/24/2023

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: 09/05/2025
• Device Model Number: 561-5000
• Device Lot Number: A201281
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/05/2023; 02/07/2025
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/02/2023; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2018
• 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