MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT TIB IMP CR INS STD SZ 4, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2019.The patient presented on (b)(6) 2019 and presented to the er with severe infection, the leg with the hardware was then amputated.Outcome: resolved on (b)(6) 2019.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 02-020-13-0240 - truliant cr cem fem cr cem left sz 4.(b)(6), 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.
Additional Manufacturer Narrative
A review of the sterile certificates and the final endotoxins reports were performed.All lots were accepted to the requirements.The reason for the reported event due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.Additionally, infection is a known surgical risk, as outlined in the ifu.D1: corrected.D4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 ; 3523771140
• MDR Report Key: 17800454
• Report Number: 1038671-2023-02339
• Device Sequence Number: 6954242
• Product Code: JWH
• UDI-Device Identifier: 10885862306470
• UDI-Public: 10885862306470
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• 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
• Device Expiration Date: 07/05/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 4, 9MM
• Device Catalogue Number: 02-022-47-4009
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 85 KG