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

Model Number TRULIANT TIB IMP PS INSERT SZ 5 10MM

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

Patient Problem Implant Pain (4561)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5383670, 200-02-32, three peg patella 32mm; 5788503, 02-022-45-5040, truliant tib fit tray cem sz 5f / 4t; 6374371, 02-020-11-0250, truliant ps cem fem ps cem left sz 5; 6424600, 201-78-15, holding pin mini sharp point 4 pk.

Event Description

It was reported a male patient, initial tka, left knee, implanted on (b)(6) 2020, was revised on (b)(6) 2022, approximately 2 years, 5 months post the initial procedure.The patient had bilateral knee replacements with the exactech system, on different dates.His right side has done very well but his left had pain and mechanical clicking for over a year.The patient became concerned after receiving the recall notice and saw his surgeon for evaluation.He was not debilitated with the knee symptoms but found them very annoying.Poly exchange for recall was performed.The patient was doing well after surgery.The explanted poly has been returned.

Manufacturer Narrative

H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient underlying conditions 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.It is noted that "clicking" can indicate positional changes in the implant that could lead to premature failure.

Event Description

No additional information has been provided, after multiple attempts.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16052481
• MDR Text Key: 306182203
• Report Number: 1038671-2022-01628
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171045
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 5 10MM
• Device Catalogue Number: 02-022-35-5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• 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 Sex: Male