MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0335
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	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op initial right tka, this male patient was revised due to severe osteolysis noted on x-rays.Femoral components were loose once dissection was completed.All components were subsequently removed and replaced with competitors components.Patient was last known to be in stable condition following the event.Devices are not returning- hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant device(s): 02-012-35-3509, 2982063 - logic tibia ps mod insrt sz 3.5, 9mm.02-012-45-3535, 2579814 - logic tibial fit tray cem 3.5f/3.5t.200-02-35, 2551741 - three peg patella 35mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of femoral loosening.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 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 FEMORAL PS CEM RIGHT SZ 3.5
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17097082
• Report Number: 1038671-2023-01303
• Device Sequence Number: 19309692
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2021
• Device Catalogue Number: 02-010-01-0335
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Male