MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 02-020-11-0240

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: serial #: (b)(4), catalog #: 200-07-32 - advanced patella 32mm 3 peg implant, serial #: (b)(4), catalog #: 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t, serial #: (b)(4), catalog #: 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm.

Event Description

It was reported that this male patient's left knee was revised due to femoral loosening.Patient complained of pain.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone and patient-related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and images/pre-revision radiographs were unable to be obtained.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 4
• 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, INC; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16250561
• MDR Text Key: 308231726
• Report Number: 1038671-2023-00073
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862314451
• UDI-Public: 10885862314451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02-020-11-0240
• Device Catalogue Number: 02-020-11-0240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Male