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

Model Number 561-0010

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

Patient Problem Arthralgia (2355)

Event Date 03/10/2023

Event Type  Injury  

Event Description

On (b)(6), 2020, a patient received total knee arthroplasty.An x-ray on (b)(6), 2023 shows an anterior femur fracture and the femoral component translated anterior.It appears that the junction box locking bolt has disengaged from the junction box.A re-revision is planned but has not yet occurred.This report is being submitted out of an abundance of caution because a proposed intervention was mentioned even though it has not yet occurred.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• Type of Device: 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: 16629071
• MDR Text Key: 312143543
• Report Number: 1722511-2023-00009
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00824409037797
• UDI-Public: (01)00824409037797(17)231207(10)A206072
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: 561-0010
• Device Lot Number: A206072
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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: 63 YR
• Patient Sex: Male