MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 years post op initial left tka, this male patient was revised due to poly wear.Everything was removed.Patient was last known to be in stable condition following the event.Product not returning - disposed at hospital.Unable to obtain photos/x-rays.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 3863653 - 02-010-04-0240 - logic cr femoral por, left, sz 4; 3614034 - 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t; 2865602 - 02-012-47-4009 - logic cr tib insert std, sz 4, 9mm; 3983051 - 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed because the component was not returned for evaluation and radiographs 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 CR TIB INSERT STD, SZ 4, 9MM
• 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18300091
• Report Number: 1038671-2023-02955
• Device Sequence Number: 7160824
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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: 11/11/2021
• Device Catalogue Number: 02-012-47-4009
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 03/31/2025
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/24/2024; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Male