MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately nine years post initial right tka, the female patient was brought back for right knee pain.The poly insert was removed with the help of an osteotome.The tibia was checked and found to be loose and removed.The femur was checked and found to be loose and removed.The patient was revised to a knee size 2 truliant logic cc femur, press fit stems, size 1 tibia and a 17 cc insert.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to patient requested implants.
Additional Manufacturer Narrative
Section d10: concomitant products: - logic tibia ps mod insrt sz 2.5 11mm (case# (b)(4)/ serial# (b)(6)).- lgc tibial fit tray cem sz 2.5f / 1.5t (cat# 02-012-45-2515 / serial# (b)(6)).
Additional Manufacturer Narrative
H3: the revision reported was likely caused by an insufficient bond between the components and the bones, which led to aseptic (non-infected) femoral and tibial loosening.Failure of the cement used to secure the femoral component and tibial tray to their respective bone, may have led to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed as the devices were not returned for evaluation.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: miguel soza
• MDR Report Key: 18735661
• Report Number: 1038671-2024-00258
• Device Sequence Number: 20269038
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• 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: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 06/30/2019
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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: COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE; THREE PEG PATELLA 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female