MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-44-2513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported by the legal department, approximately 8 years post op the initial tka, this 69 y/o female patient was revised due to polyethylene wear and periprosthetic osteolysis of the right knee joint.
Additional Manufacturer Narrative
A2.Added patient age at time of incident.H6.The revision reported in (b)(4) may have been the result of prosthesis wear and subsequent particle-induced osteolysis.However, the reported prosthesis wear, osteolysis, and contributions of implant positioning and/or patient-related conditions to the sequence of events cannot be confirmed as the devices were not available for evaluation and limited information was provided at the time of evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10: (b)(6) 200-02-35 three peg patella 35mm.(b)(6) 02-010-01-0325 logic femoral ps cem right sz 2.5.(b)(6) 02-012-41-2525 logic tibia traptray cem sz 2.5f/2.5t.
Event or Problem Description
It was reported that approximately 91 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening, pain, swelling, synovial cyst and osteolysis.Initial surgery and revision surgery operative notes were provided.Post operative report diagnosis was failed right total knee secondary to femoral component loosening.Intraoperatively the surgeon observed significant synovial effusion, a large posterior synovial cyst and osteolysis of the proximal fibula.It is noted the extensive synovial expansion was secondary to foreign body reaction and the femoral component loosening.There was no evidence of infection.The tibial component was well fixed.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation 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 2.5, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16207245
• Report Number: 1038671-2023-00047
• Device Sequence Number: 17496772
• Product Code: JWH
• UDI-Device Identifier: 10885862173539
• UDI-Public: 10885862173539
• 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: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2025

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: 08/14/2020
• Device Model Number: 02-012-44-2513
• Device Catalogue Number: 02-012-44-2513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 04/04/2023; 05/20/2024; 05/05/2025
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 04/10/2023; 12/19/2024; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown