MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE SYSTEM; UNICOMPARTMENTAL TIBIAL TRAY

Model Number	762-4200A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient with osteoarthritis received unicompartmental knee arthroplasty.On (b)(6) 2025, a postoperative x-ray revealed a tibial condyle fracture.On (b)(6) 2025, the patient was revised to add a bone plate to reinforce the fracture.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: UNICOMPARTMENTAL TIBIAL TRAY
• 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: 23719897
• Report Number: 1722511-2025-00025
• Device Sequence Number: 8532004
• Product Code: HSX
• UDI-Device Identifier: 00822409120130
• UDI-Public: (01)00822409120130(17)290515(10)A303559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: 762-4200A
• Device Lot Number: A303559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: 78 YR
• Patient Sex: Female