MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; SEE H10

Catalog Number	02-012-44-5015
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.H6.Investigation results - there is no specific information provided for the optetrak logic device.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a first left knee arthroplasty revision on (b)(6) 2017 and then approximately 5 years later was revised for a second time on (b)(6) 2023 for osteolysis, bone loss, synovitis component loosening, polywear and debonding, instability, joint pain, stiffness, and swelling, foreign body reaction synovitis: insufficient information.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H10.D10.Concomitant medical products information: optetrak logic cc femoral size 5 (02-010-06-0250, 4588495); optetrak ext stem femur (204-40-16, 3711516); screw bone 7mm optetrak tib knee ext stem (204-70-00, 4743305); logic post.Aug.Block size 5 (02-010-06-0551, 4417039); logic post.Aug.Block size 5 (02-010-06-0551, 4544403) updated/additional information ¿ a2.A3.D4.G1.G2.G4.H4.H6.H7.H9.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.
Event or Problem Description
Revision op report - diagnosis: left knee polyethylene failure findings: poly wear and debonding, osteolysis.The entire joint was inspected showing significant osteolytic synovitis.Chronically inflamed synovium was resected from the suprapatellar pouch and anterior surface of the bony femur.The patient arrived in pacu in stable condition with no apparent complications.There is no additional information available.
Additional Manufacturer Narrative
Additional manufacturer narrative- b5 additional information, h6.There is no additional information available.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 17080679
• Report Number: 1038671-2023-01277
• Device Sequence Number: 2173720
• Product Code: JWH
• UDI-Device Identifier: 10885862173744
• UDI-Public: 10885862173744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 02-012-44-5015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 04/25/2024; 06/05/2024
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 04/30/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male