MAUDE Adverse Event Report: TRULIANT TIB IMP CRC INSERT SZ 4.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-022-51-4511

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

Patient Problem Bacterial Infection (1735)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation.(d10) concomitant device(s): 02-020-13-0345 - truliant cr cem fem cr cem right sz 4.5: 5225138 02-022-45-4555 - truliant tib fit tray cem sz 4.5f/5.5t: 5144043 200-07-35 - advanced patella 35mm 3 peg implant: 5410208.

Event Description

As reported by the exactech truliant knee clinical study, the 62 year old male patient had an initial right tka on (b)(6) 2018 and presented with infection, 0 year(s) and 4 month(s) post initial procedure on (b)(6) 2019.(b)(6) 2018: patient reports mild swelling, moderate pain, and no drainage.(b)(6) 2019: moderate swelling, pain decreased.(b)(6) 2019: patient reports moderate swelling, decreased pain - arthrocentesis; synovasure revealed + staphylococcus panel.Revision scheduled (b)(6) 2019.Revision: debridement, roh, insert spacer w drug eluting stent.Refer to id.This case is related to (b)(4).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 on (b)(6) 2019 was revision.The outcome is reported as continuing.No device return anticipated due to being a clinical trial study.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4.5, 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• MDR Report Key: 18717003
• MDR Text Key: 335526694
• Report Number: 1038671-2024-00236
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K171045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Type of Report: Initial
• Report Date: 02/15/2024

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: 02-022-51-4511
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2018
• 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