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

Model Number 200-07-32

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 01/09/2020

Event Type  Injury  

Event Description

As reported by the truilant knee clinical study, this 65 y/o obese female patient was experiencing patellar clunk syndrome, patient declined surgical intervention (arthroscopy) at this time.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.No additional information.

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent condition cannot be conclusively determined; however, it may have been related to the patient condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Patellar clunk is caused by a fibrous nodule of scar tissue at the posterior surface of the distal quadriceps tendon/superior patellar pole catching on the box of the femoral component during knee extension (patellar clunk syndrome (b)(6) 2021).Concomitant device(s): 02-020-11-0340 - truliant ps cem fem ps cem right sz 4, (b)(4), 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm, (b)(4).Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t, (b)(4).

Manufacturer Narrative

Section h11: the following sections have corrected information: (d1) brand name: truliant ps cem fem ps cem right sz 4, (d4) catalog number: 02-020-11-0340, serial number: (b)(6), expiration date: 06-sep-2027, unique identifier (udi) #: (b)(4).(d10) concomitant device(s): 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm, s028289, serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t, 5789055, 200-07-32 - advanced patella 32mm 3 peg implant 6187770, (g4) pma/510(k)number: k170240, (h4) device manufacture date: 06-sep-2017.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT 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.; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16005509
• MDR Text Key: 305716333
• Report Number: 1038671-2022-01608
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862314567
• UDI-Public: 10885862314567
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 200-07-32
• Device Catalogue Number: 02-020-11-0340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/20/2022
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0023-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 99 KG