MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-13-0340
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Loss of Range of Motion (2032); Joint Laxity (4526); Implant Pain (4561)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 28 months after a right total knee replacement procedure, a female patient underwent a revision procedure to address a small nondisplaced distal femur fracture on the medial side.Patient claims that she fell because her knee was unstable "because of the recall".Operative findings indicated the total knee components were well-fixed, and the poly insert was removed.There were no signs of wear on the poly, and it had no noticeable oxidation or delamination.A new size 4, 12mm poly was inserted and implanted.A competitor's retrograde nail was used to repair the fracture.Patient was last known to be in stable condition following the event.Images of the liner and x-rays were received.The device is not available for evaluation due to the poly being kept after surgery concluded.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-022-47-4011 - truliant tib imp cr ins std sz 4, 11mm.(b)(6) - 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.(b)(6) - 200-07-32 - advanced patella 32mm 3 peg implant.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00956.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
H6: corrected investigation clinical codes.

• Brand Name: TRULIANT CR CEM FEM CR CEM RIGHT SZ 4
• 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: 22666404
• Report Number: 1038671-2025-02638
• Device Sequence Number: 3677831
• Product Code: JWH
• UDI-Device Identifier: 10885862314697
• UDI-Public: 10885862314697
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 02-020-13-0340
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/01/2025
• Date Device Manufactured: 12/18/2019
• 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: Hospitalization; Required Intervention
• Patient Sex: Female