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

Catalog Number	02-020-14-0330
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Aseptic loosening (4883)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee replacement on the right side.4 years following, the patient experienced limited range of motion with pain in the right tka, subject impacted the knee 2 months prior and underwent physical therapy rehabilitation.Subsequently, the patient has now experienced aseptic femoral loosening found on the radiographs.Patient deigns pain but indicates that rom is more of a concern; at this visit was 0-85 degrees flexion.As a result, approximately 5 years after initial replacement, the patient is again undergoing physical therapy rehabilitation.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
D10: 02-022-51-3009 - truliant tib imp crc insert sz 3, 9mm: (b)(6); 02-022-55-3030 - truliant por tib tray size 3f/3t: (b)(6); 200-02-35 - three peg patella 35mm: (b)(6).The reason for the reported event cannot be confirmed from the information provided, but may have been due to femoral loosening and loss of range of motion.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images or 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 CR POR FEM CR POR RIGHT 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
• MDR Report Key: 22471685
• Report Number: 1038671-2025-02475
• Device Sequence Number: 8113038
• Product Code: JWH
• UDI-Device Identifier: 10885862315113
• UDI-Public: 10885862315113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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 Catalogue Number: 02-020-14-0330
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 04/22/2019
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Male