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

Model Number LOGIC TIBIA PS MOD INSRT SZ 4 11MM

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Synovitis (2094)

Event Date 01/19/2023

Event Type  Injury  

Event Description

It was reported via a legal notification that a male patient, initial right knee implanted with a size 4/11 mm optetrak logic ps tibial insert on (b)(6) 2017, had x-rays on (b)(6) 2022, which showed moderate swelling.Plaintiff¿s orthopedist concluded ¿there is a concern for premature wear, osteolysis, and loosening, and recommended an mri and aspiration of the bilateral knees¿.On or about (b)(6) 2022, the results of the knee aspirations revealed abnormally high levels of yellow/hazy synovial fluid in the right and left knees, and it was determined the plaintiff would require revision surgery as a result of the failure of the devices.Revision surgery for the right knee is scheduled for (b)(6) 2023.No further information.

Manufacturer Narrative

No device returned as it remains implanted.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 subsequent revision cannot be conclusively determined, insufficient information.Wear to articular surfaces, osteolysis, and loosening are well known device specific risks.

Event Description

As reported via legal documentation the patient had a right knee replacement on (b)(6) 2017.Approximately 5 years and 9 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.Revision op report - (b)(6) 2023.Diagnosis: failed right knee replacement with synovitis.A preoperative mri had shown synovitis secondary to polyethylene wear but the components were well fixed.There was very extensive synovitis and a very thorough synovectomy of the joint was performed.Some wear on the liner was seen.

Manufacturer Narrative

Added information to a2, e3, and e4.H6: investigation results - the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC
• 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: 16067475
• MDR Text Key: 306326700
• Report Number: 1038671-2022-01638
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

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 Expiration Date: 02/01/2024
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 11MM
• Device Catalogue Number: 02-012-35-4011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 11/01/2023
• Supplement Dates FDA Received: 05/24/2023; 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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-0021-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male