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 Failure of Implant (1924); Inflammation (1932)

Event Date 12/08/2016

Event Type  Injury  

Event Description

It was reported via a legal notification, that a male patient, initial left knee implanted with a size 4/11 mm optetrak logic ps tibial insert on (b)(6) 2016, 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 failure of the devices.Upon information and belief, plaintiff¿s will require revision surgery on his left knee for issues included but not limited to polyethylene wear, bone loss, and/or component loosening.Revision surgery for the left knee is undetermined at this time.No further information known.

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.

Manufacturer Narrative

As a result of additional information provided, the following fields have been updated: a2, b6, d6b, and h6.Added information to e3 and e4.H3: investigation results - the revision reported was likely the result of prosthesis wear and osteolysis.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 and osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.Corrected d4 serial number.

• 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: miguel sosa ; 3523771140
• MDR Report Key: 16064642
• MDR Text Key: 306316687
• Report Number: 1038671-2022-01637
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 11MM
• Device Catalogue Number: 02-012-35-4011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• 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: 81 YR
• Patient Sex: Male