MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	02-022-35-3509
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 6616265 02-020-12-0335 - truliant ps por fem ps por right sz 3.5, 7004702 02-022-55-3525 - truliant por tib tray size 3.5f/2.5t, 30000 02-029-99-1001 - fluted headless pin 3.0" square head, pk2, 359010 02-029-99-1002 - threaded head pin 2.3" square head, pk2, 6982469 200-07-29 - advanced patella 29m 3 peg implant.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2021.Has not yet been explanted.The patient had and will continue to have pain and suffering.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Additional manufacturer narrative- additional information was added.Report 1 of 3.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
Revision 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
This follow-up report is being submitted to relay additional and/or corrected information.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 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17332905
• Report Number: 1038671-2023-01673
• Device Sequence Number: 17804100
• Product Code: JWH
• UDI-Device Identifier: 10885862304346
• UDI-Public: 10885862304346
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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,Followup
• Report Date (Section B): 05/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 02-022-35-3509
• Device Catalogue Number: 02-022-35-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 05/28/2024; 05/29/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 06/19/2024; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IN INITIAL REPORT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female