MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number TRULIANT TIB IMP CRC INSERT SZ 4, 15MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 06/21/2022

Event Type  Injury  

Event Description

It was reported via clinical study that the 68 yo male patient experienced a patella tendon rupture.After reporting increased pain in clinic on (b)(6) 2022, the x-rays showed the patella to be high-riding.The surgeon determined the patella tendon had ruptured, and patella-tendon repair surgery was scheduled.The patient was revised on (b)(6) 2022.The outcome was last known as resolved.

Manufacturer Narrative

D10.Concomitants: truliant femoral component ref.No.(b)(4).Tibial tray ref.No.(b)(4).

• Brand Name: TRULIANT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17421510
• MDR Text Key: 320022576
• Report Number: 1038671-2023-01809
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862307781
• UDI-Public: 10885862307781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152170
• 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: 07/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
• Device Catalogue Number: 02-022-51-4015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: Black Or African American