MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE REVISION SYSTEM; JUNCTION BOX

Model Number 561-0510

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Arthralgia (2355)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, a femoral knee construct was x-rayed and the junction box was revealed to be out of position.This report is being submitted because an intervention could result.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• Type of Device: JUNCTION BOX
• 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: 19013338
• MDR Text Key: 339103383
• Report Number: 1722511-2024-00006
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00822409037827
• UDI-Public: (01)00822409037827(17)260702(10)A218942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

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
• Device Operator: Health Professional
• Device Model Number: 561-0510
• Device Lot Number: A218942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male