MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; SEE H10

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 65 yo male patient, initial left knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 3 years 3 months post the initial procedure.The patient complained of pain.Loose femur indicated.No surgical delays reported.The patient was last known to be in stable condition following the event.No devices returning due to ¿chain of command.¿ due to recall hospital will not release the implants.
Additional Manufacturer Narrative
Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.200-07-35 - advanced patella 35mm 3 peg implant.The revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the device was not returned for evaluation.

• Brand Name: TRULIANT
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16557246
• Report Number: 1038671-2023-00452
• Device Sequence Number: 20106007
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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 Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 5
• Device Catalogue Number: 02-020-11-0250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male