MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 02-020-11-0245 , truliant ps cem fem ps cem left sz 4.5, (b)(6), 200-07-35, advanced patella 35mm 3 peg implant (b)(6), 201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t, (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm, (b)(6).
Event or Problem Description
As reported, approximately 6 years and 2 months post initial left total knee arthroplasty (tka), the patient was revised to a competitor prosthesis due to complaints of pain, loose femur, and recalled insert and patella.The event was not related to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The reason for the revision reported was likely caused by an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the bone, may have lead to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed as the devices were not returned for evaluation.Wear could not be confirmed for the tibial insert or the patella from the provided images.H6: corrected investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 13MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20668618
• Report Number: 1038671-2024-04372
• Device Sequence Number: 20675607
• Product Code: JWH
• UDI-Device Identifier: 10885862304568
• UDI-Public: 10885862304568
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 01/02/2026
• Device Catalogue Number: 02-022-35-4513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 08/07/2025
• Date Device Manufactured: 01/03/2018
• 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: 64 YR
• Patient Sex: Male