MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-41-3030
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Joint effusion (4849)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 200-02-32 three peg patella 32mm (b)(6), 02-010-01-0230 logic femoral ps cem left sz 3 (b)(6), 02-012-41-3030 logic tibia traptray cem sz 3f/3t (b)(6), 02-012-35-3011 logic tibia ps mod insrt sz 3 11mm (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00617, 1038671-2024-05078, 1038671-2024-05080.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported via legal documentation that approximately 53 months after having a left total knee replacement the patient underwent a revision surgical procedure to address prosthesis wear, loosening, pain and instability.The post operative diagnosis noted aseptic loosening tibial component and osteolysis.Intraoperatively, the surgeon observed significant synovitis, wear of the polyethylene liner and significant fibrous tissue with osteolysis beneath the femoral component.It was noted there was no evidence of infection.The tibial component was noted to be loose and easily removed and with osteolysis beneath at the medial aspect.The patella was noted to be well fixed, but with some wear with osteolysis that was debrided.There were no medical or surgical interventions reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) femoral and tibial loosening was likely the result of an insufficient bond between the implants and the bone.The prosthesis wear and osteolysis may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed because the components were not returned for evaluation 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 TRAPTRAY CEM SZ 3F/3T
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21047217
• Report Number: 1038671-2024-05084
• Device Sequence Number: 3409096
• Product Code: JWH
• UDI-Device Identifier: 10885862003171
• UDI-Public: 10885862003171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 12/01/2021
• Device Catalogue Number: 02-012-41-3030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 12/05/2016
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male