MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-1509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint effusion (4849)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): z99007 - logic tka unassigned.Zinfo-01 - unassigned.Zoscl-01 - unassigned.Zream-01 - unassigned.Tn190-119-05 - m-class 19x1.19x105 (b)(6).02-012-47-1509 - logic cr 1.5 - 9mm 4132885.200-02-32 - 3 / 32mm (b)(6).
Event or Problem Description
It was reported that this patient's right knee was revised approximately 4 years 5 months post op.The patient had a total knee arthroplasty using cr sdt tibial insert which started causing knee swelling and pain, the surgeon diagnosed the infection and wear of the tibial insert, then revision surgery for the replacement was performed.Wear on posterior side was observed.Surgeon decided to replaced to a competitors device.Patient was last known to be in stable condition following the event.
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 prosthesis wear and an infection, as stated in the experience report.The wear was likely due to malalignment between the femoral component and tibial tray which led to prosthesis wear of the tibial insert.The reason for the reported infection cannot be conclusively determined, but may be related to an underlying patient condition.However, this cannot be confirmed and possible contributions from patient related considerations could not be assessed because the components were not returned for evaluation and sufficient clinical information was 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 CR TIB INSERT STD, SZ 1.5, 9 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20553196
• Report Number: 1038671-2024-04157
• Device Sequence Number: 14265560
• Product Code: JWH
• UDI-Device Identifier: 10885862144331
• UDI-Public: 10885862144331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/13/2025

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: 10/02/2023
• Device Catalogue Number: 02-012-47-1509
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female