MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM; SEE H10

Catalog Number	02-012-44-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer these devices are used for treatment not diagnosis.Pending investigation.No other information is available.
Event or Problem Description
As reported by the legal brief, on (b)(6) 2016, a patient underwent bilateral total knee replacement surgery.During this procedure, patient was implanted with an optetrak logic polyethylene psc tibial insert in the right knee.It is stated that it is likely the patient will undergo revision surgery on her right knee to remove the "failed" optetrak device, there is no information if the patient was revised.No additional information is available.
Additional Manufacturer Narrative
H6: investigation results - the potential 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, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected information: b2, b3, d2b, h6 clinical codes, impact code.Additional information: b5, d6b, d10, g, g2, g3, h6 component code.D10: 4258256 02-012-41-2020 - logic tibia traptray cem sz 2f/2t.4517612 02-010-01-0320 - logic femoral ps cem right sz 2.Three peg patella.
Event or Problem Description
It was reported via legal documentation approximately 81 months after a right total knee replacement procedure, the patient underwent right knee revision procedure to address chronic knee pain and patellar component loosening.A revision operative report was provided.Intraoperatively the surgeon observed inflamed synovium and fibrotic tissue once the arthrotomy was made.It was noted there was no sign or concern for infection.The surgeon observed notable osteolysis surrounding the femoral component and was noted to be well fixed.It was elected to leave the original femoral component in place.Additionally, the tibial component was found to be well fixed, and it was elected to leave the original tibial component in place.The patella was noted to be loose and was exchanged.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
The potential 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, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17732778
• Report Number: 1038671-2023-02246
• Device Sequence Number: 17742275
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2025

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: 07/19/2024
• Device Catalogue Number: 02-012-44-2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 12/07/2023; 02/26/2025
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/21/2023; 02/20/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female