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

Model Number 561-0510

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

Patient Problem Arthralgia (2355)

Event Date 02/07/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, a femoral sleeve construct was revised.After exposing the knee, it was noted that the junction box slid anterior and posterior on the femoral component.The morse taper of the junction box into the sleeve was intact and strong.

• 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: 18831376
• MDR Text Key: 336859773
• Report Number: 1722511-2024-00003
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00822409037827
• UDI-Public: (01)00822409037827(17)290620(10)A270898
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2024

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: A270898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2022
• 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: 64 YR
• Patient Sex: Male