MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, RIGHT, SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): femoral component cr, porous size 5, - 02-010-04-0350 - 3866284.Fit tibial tray cemented size 5f/4t - 02-012-45-5040 - 4118295.Three peg patella, 38mm - 200-02-38 - 4375898.Logic tib insert impl crc, sz 5, 11mm - 02-012-51-5011 - 4599421.
Event or Problem Description
It was reported that this 67 y/o male patient's right knee was revised approximately 3 years post op.The patient was revised due to femur loosening caused by osteolysis from tibia poly and patella wear.All components were removed and revised by other company¿s revision knee.Patient was last known to be in stable condition following the event.Product not returning - disposed at hospital.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral 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, femoral loosening, and osteolysis could not be determined as the devices were not returned for evaluation.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1, b2, h2, h6.The revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone, which led to the reported aseptic (non-infected) femoral 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, femoral loosening, and osteolysis could not be determined as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: LOGIC CR FEMORAL POR, RIGHT, SZ 5
• 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: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 18498778
• Report Number: 1038671-2024-00085
• Device Sequence Number: 20784101
• Product Code: JWH
• UDI-Device Identifier: 10885862158406
• UDI-Public: 10885862158406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2025

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: 02/17/2020
• Device Catalogue Number: 02-010-04-0350
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 04/15/2024; 05/09/2025
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/23/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 103 KG