MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0230
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) 02-022-35-3009 - truliant tib imp ps insert sz 3 9mm (b)(6) 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t (b)(6) 200-07-32 - advanced patella 32mm 3 peg implant.
Event or Problem Description
As reported, the 74 year old female patient had an initial left tka on (b)(6) 2018.The patient complained of pain and was revised on (b)(6) 2024 due to a loose femur and bad poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
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.This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b5, h6 component code, type of investigation, investigation findings, and investigation conclusions.The following sections were corrected: b2, h6 clinical code and problem code.
Event or Problem Description
It was reported that approximately 76 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, loosening, pain, stiffness, swelling, discomfort, weakness and instability.
Additional Manufacturer Narrative
The reason for the revision reported was likely the result of pain, which was caused by prosthesis wear, instability, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The reason for the reported loosening cannot be confirmed as the devices were not returned for evaluation.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-bone interface and/or cement-implant interface; however, this cannot be confirmed.Prosthesis wear of the tibial insert could not be confirmed from the images provided.Possible causes for polyethylene wear for the patella include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability or any combination of these possibilities.H6: corrected health effect and investigation clinical codes.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• 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: 19296909
• Report Number: 1038671-2024-01195
• Device Sequence Number: 5920182
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• 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: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: 02-020-11-0230
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 04/22/2025; 07/23/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/14/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female