MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM; SEE H10

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported via legal department, that patient, underwent initial left knee replacement surgery on (b)(6) 2015.He was implanted with an optetrak device.On (b)(6) 2022, plaintiff underwent left knee revision surgery, approximately 7 years 8 months post initial procedure, to remove the failed polyethylene liner due to accelerated and preventable wear of the polyethylene tibial insert.No device return anticipated due to this being a legal case.
Additional Manufacturer Narrative
As a result of additional information received, the following fields have been updated: a2, a3, b5, and h6.Information has been added to e4.H6: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the device and the bone, resulting in aseptic (non-infected) patella loosening.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, osteolysis, and patella loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Event or Problem Description
As reported via legal department, a patient underwent initial left knee replacement surgery on (b)(6) 2015.He was implanted with an optetrak device.On (b)(6) 2022, the patient underwent left knee revision surgery, approximately 7 years 8 months post initial procedure, to remove the failed polyethylene liner due to accelerated and preventable wear of the polyethylene tibial insert.Revision op report ((b)(6) 2022) diagnosis: left knee osteolysis due to polyethylene wear.Findings: global instability, large effusion without gross evidence of infection.Synovitis consistent with poly wear.Loosening patellar component.Femoral component not grossly loose however deboned from cement mantle and removed with bone tamp with no attached cement on back side of implant.Tibia well fixed.Massive osteolysis tibia worse medial and posteromedially with uncontained defect.Aori 2b bone loss tibia and femur.There were no complications.A surgical defrief was performed.The patient was transferred to the recovery room in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM
• Common Device Name: SEE H10
• 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: 16487667
• Report Number: 1038671-2023-00357
• Device Sequence Number: 14927416
• Product Code: JWH
• 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: 2015
• Device Explanted Year: 2022
• 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): 06/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2021
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM
• Device Catalogue Number: 02-012-44-3513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 05/27/2026
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 10/06/2023; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male