MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3509
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): concomitants: 4060079: 200-02-35 - three peg patella 35mm.5037097: 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t.5099910: 02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5.5100605: 02-022-35-3509 - truliant tib imp ps insert sz 3.5 9mm.
Event or Problem Description
As reported, approximately 5 years post op initial left tka, this 59 y/o male patient was revised due to instability.Femur, liner and patella were exchanged.Patient was last known to be in stable condition following the event.No x-rays provided, unable to obtain.No product return - with lawyer.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, osteolysis, and instability.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, osteolysis, and instability could not be determined as the devices were not returned for evaluation, and images of the patella and radiographs were not provided.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, osteolysis and instability.The reported wear could not be confirmed for the patella component, and the provided images of the tibial insert appear unremarkable with respect to wear.Possible causes for the instability might include malalignment between the implants, improper positioning of the implants, or inadequate soft tissue balancing.The extent and root cause of the prosthesis wear, osteolysis, and instability could not be determined as the devices were not returned for evaluation, and images of the patella and radiographs were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 17164934
• Report Number: 1038671-2023-01403
• Device Sequence Number: 5771825
• Product Code: JWH
• UDI-Device Identifier: 10885862304346
• UDI-Public: 10885862304346
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 02/10/2025

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 Expiration Date: 01/03/2026
• Device Catalogue Number: 02-022-35-3509
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 03/28/2024; 02/10/2025
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 04/18/2024; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 59 YR
• Patient Sex: Male