MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Joint effusion (4849)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-010-03-0335 - logic cr femoral cem, right, sz 3.5 4459530 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t 4424833.
Event or Problem Description
It was reported that this patient had an original exactech total knee arthroplasty (tka) on their right side.The patient returned to surgeons office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled poly implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient underwent a poly tibial insert swap and patella swap.Patient was last known to be in stable condition.Product will not be returned; the implant(s) were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
The revision reported in (b)(4) was likely the result of pain, instability, and prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis, however, it cannot be confirmed.H6: corrected medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
• 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; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20523763
• Report Number: 1038671-2024-04109
• Device Sequence Number: 7983981
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 06/26/2025

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: 05/06/2022
• Device Catalogue Number: 02-012-49-3511
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 06/26/2025
• Date Device Manufactured: 06/07/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male