MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. KLASSIC BLADE OFFSET FEMORAL STEM, POROUS, SIZE 6; KNEE FEMORAL IMPLANT

Catalog Number	3107.06.000
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received feedback from both the surgeon and the sales rep regarding this revision case.Both commented on the age of the patient combined with the poor bone quality due to osteoporosis and type c femur as being the main contributing factors to the spontaneous fracture in this case.This is the first reported incident of a non-fall related femur fracture with any tjo stems.There are no deviations or nmrs for the femur lot that would identify anything abnormal about the femur used in the primary case.Therefore, there is no conclusive finding related to the stem itself or the procedure, the likely cause is patient related due to poor bone quality.
Event or Problem Description
A serious injury resulted in the need for surgical intervention due to a spontaneous vancouver type b2 fracture with stem subsidence 10 days after the primary tha surgery with no reported fall or incident by the patient.Surgeon reported the patient was very osteoporotic with a type c femur.

• Brand Name: KLASSIC BLADE OFFSET FEMORAL STEM, POROUS, SIZE 6
• Common Device Name: KNEE 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 ; 8014866117
• MDR Report Key: 24449125
• Report Number: 3008544874-2026-00002
• Device Sequence Number: 10443312
• Product Code: LPH
• UDI-Device Identifier: 00814703012341
• UDI-Public: 00814703012341
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K151440
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 3107.06.000
• Device Lot Number: M231130-6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female