MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS POR FEM PS POR LEFT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-35-4511
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: serial #: (b)(4), category #: 02-022-55-4535 - truliant por tib tray size 4.5f/3.5t, serial #: (b)(4), category #: 02-020-12-0245 - truliant ps por fem ps por left sz 4.5, serial #: (b)(4), category #: 200-07-32 - advanced patella 32mm 3 peg implant.Correction/removal number: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2021.The patient was revised on (b)(6) 2023 due to pain and recalled poly.There was no reported breakage of devices or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H10.Additional information- d10 truliant tib imp ps insert sz 4.5 11mm h11.Correction ¿ the device is identified as a femoral component for loosening d1a, d4, g4 510k, h4, h7 the femoral component is not a recall device.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and the femoral loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and the femoral loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and the femoral loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT PS POR FEM PS POR LEFT SZ 4.5
• 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16292820
• Report Number: 1038671-2023-00096
• Device Sequence Number: 6273073
• Product Code: JWH
• UDI-Device Identifier: 10885862314819
• UDI-Public: 10885862314819
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

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 Model Number: 02-022-35-4511
• Device Catalogue Number: 02-020-12-0245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/30/2024; 03/05/2024; 02/13/2025; 03/24/2025
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/21/2024; 03/05/2024; 02/18/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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: 62 YR
• Patient Sex: Female