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

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this 68 year old, female patient had a tka on (b)(6) 2021.The patient was complaining of pain and was revised on (b)(6) 2022 due to a loose femoral component.There is no reported breakage of a device or surgical delay/prolongation.The devices are not returning.
Additional Manufacturer Narrative
Pending device evaluation.Concomitant medical products: 02-022-35-3009 - truliant tib imp ps insert sz 3 9mm, s108891.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the component was not returned for evaluation.H7: z-0023-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, h1, h3, h6 clinical code and investigation findings and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15105049
• Report Number: 1038671-2022-00842
• Device Sequence Number: 17181184
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

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 Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• Device Catalogue Number: 02-020-11-0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 04/13/2023; 09/24/2025
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 04/27/2023; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female