MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t, (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm, (b)(6) 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
It was reported that a 62 yo male patient, initial left knee implanted in (b)(6) 2013, underwent a revision procedure in (b)(6) 2025, approximately 11 years 1 month post the initial procedure.The surgeon revised the patient¿s logic femoral component, tibial insert and patella due to osteolysis.There was significant polyethylene wear on the tibial insert and patella.There was no cement adhered to the logic femoral component once it was removed.Cement was only present on the femur.The surgeon left the logic tibial components in place as they were well fixed.He revised the femur to logic cc components and replaced the patella with an active e truliant 3 peg patella.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return as the facility held the product.No device images were provided.No further information.This is report 3 of 3 for this event/patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported is likely the result of a combination of osteolysis, prosthesis wear of the tibial insert and patella, and femoral loosening over 11 years of implantation.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis and subsequent loosening.However, the reported failures cannot be confirmed, contributions of loosening and prosthesis wear to the sequence of events, and potential user or patient-related considerations could not be assessed as the devices were not available for evaluation and no images or radiographs were 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 FEMORAL PS CEM LEFT SZ 4
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21315904
• Report Number: 1038671-2025-00683
• Device Sequence Number: 20942010
• Product Code: JWH
• UDI-Device Identifier: 10885862001160
• UDI-Public: 10885862001160
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 12/09/2018
• Device Catalogue Number: 02-010-01-0240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 63 KG