MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-022-44-4009

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 02-010-06-0340 - logic cc femoral size 4, right 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 200-07-35 - advanced patella 35mm 3 peg implant.

Event Description

As reported by the exactech truliant knee clinical study, the 62 year old male patient had an initial right tka on 13-nov-2018 and presented with infection, 0 year(s) and 1 month(s) post initial procedure on (b)(6) 2018.12-11-2018 mild swelling, moderate pain; (b)(6) 2019: moderate swelling, arthrocentesis revealed +staphylococcus panel.Revision schedule (b)(6) 2019.Referred to id.Iv abx therapy x 6 weeks.Revision scheduled (b)(6) 2019.The case report form indicates that this event is unlikely related to the device and definitely related to the procedure.The report also indicates that the action taken was revision on (b)(6) 2019.The outcome is reported as resolved on (b)(6) 2019.No device return anticipated due to being a clinical trial study.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18725508
• MDR Text Key: 335718075
• Report Number: 1038671-2024-00249
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

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 Operator: Health Professional
• Device Catalogue Number: 02-022-44-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Race: White