MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-12-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient experienced a right knee surgical procedure approximately 2 years 2 months post initial implant.Preoperative diagnoses: failed right total knee arthroplasty secondary to premature polyethylene wear from a recalled polyethylene insert and aseptic loosening of the femoral component.Revision right.Total knee arthroplasty of femoral, tibial, and patellar components.Patient was revised to competitor's implants.Infection work-up was negative.There was some early polyethylene synovitis, but no signs of infection or purulence.There was early wear of the patellar button on the lateral facet with flattening, it was exchanged.On gross inspection of the tibial insert, there were no obvious signs of significant wear, there were a couple of areas of some pinning.There was failure of bony ingrowth for the femoral component, it was removed.Tibial component was removed.Tile patient was awoken from anesthesia and transferred to the recovery room in stable condition.No complications.Device will not be returned.No breakage of device or surgical delay/prolongation reported.There is no additional information available.
Additional Manufacturer Narrative
Related: mfr #1038671-2023-01673 report 1 of 3.Mfr #1038671-2024-01999 report 2 of 3.Additional manufacturer narrative- report 3 of 3.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3: the reason for the revision reported may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Failure of the bone to thoroughly grow into the femoral component may have lead to loosening at the bone-implant interface; however, this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.

• Brand Name: TRULIANT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19567727
• Report Number: 1038671-2024-02000
• Device Sequence Number: 6017991
• Product Code: JWH
• UDI-Device Identifier: 10885862314901
• UDI-Public: 10885862314901
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 02-020-12-0335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female