MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. KLASSIC FEMUR; FEMORAL IMPLANT

Catalog Number	5105.03.000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After inspection of the returned implant and review of manufacturing records we were unable to determine the cause of implant loosening.Implant records show that this lot of femurs was made to specification.No other complaints have been reported regarding this implant.This lot of femurs had a quantity of (b)(4) 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.

• 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: bobbi siddoway ; 1567 east stratford avenue; salt lake city, UT 84106 ; 8014866070
• MDR Report Key: 20303275
• Report Number: 3008544874-2022-00001
• Device Sequence Number: 21049390
• Product Code: JWH
• UDI-Device Identifier: 00814703016653
• UDI-Public: 00814703016653
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153310
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5105.03.000
• Device Lot Number: C1322023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2019
• 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 Age: 57 YR
• Patient Sex: Female