MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. Klassic Femur; Femoral Implant

Catalog Number	5105.06.000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No correction is required.This is the second occurrence of implant loosening for a cr femur (rga 1771).The occurrence of implants loosening will continue to be monitored.This lot of femurs had a quantity of 52 and all have been consumed with no other reports of loosening.
Event or Problem Description
Patient underwent revision total knee arthroplasty due to loosening of femoral implant.
Event or Problem Description
Patient underwent revision total knee arthroplasty due to loosening of femoral implant.
Additional Manufacturer Narrative
No correction is required.This is the second occurrence of implant loosening for a cr femur (rga 1771).The occurrence of implants loosening will continue to be monitored.This lot of femurs had a quantity of 52 and all have been consumed with no other reports of loosening.This mdr is being submitted as a part of correcting initial mdr based on mdr reporting process, and fda adverse event reporting requirement.Device performance and/or risk profile are not impacted.

• Brand Name: Klassic Femur
• Common Device Name: Femoral Implant
• Manufacturer (Section D): TOTAL JOINT ORTHOPEDICS, INC.; 1567 east stratford avenue; salt lake city UT 84106
• Manufacturer Contact: kaisa cardall ; 1567 e stratford ave; salt lake city, UT 84106 ; +1(801)486-6070
• MDR Report Key: 24926382
• Report Number: 3008544874-2026-00003
• Device Sequence Number: 5180794
• Product Code: JWH
• UDI-Device Identifier: 00814703016684
• UDI-Public: 00814703016684
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153310
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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 Catalogue Number: 5105.06.000
• Device Lot Number: 55687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown