MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately twenty-one days post initial right tka, the 54 y/o female patient had the tibial insert exchanged for a new one of the same size during a wash out procedure due to infection.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The device is not available for evaluation due to being against hospital policy.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
A review of the sterile certificates and/or the final endotoxins report was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17400517
• Report Number: 1038671-2023-01787
• Device Sequence Number: 5922008
• Product Code: JWH
• UDI-Device Identifier: 10885862307705
• UDI-Public: 10885862307705
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Model Number: TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
• Device Catalogue Number: 02-022-51-3511
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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: ADVANCED PATELLA 35 MM 3 PEG IMPLANT; GPS IMPLANT KIT V2; SMALL HEADED SHARP PIN, 1 1/8" 4 PACK; THREADED PIN SIZE 2.3 COLLARED 2PK (2); THREADED PIN SIZE 3.0 COLLARLESS 2PK; THREADED PIN SIZE 5.1 COLLARLESS 2PK; TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5; TRULIANT TRAY, CEM SZ 3.5F/3T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female