MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 5.5 years after a total right knee replacement, the patient was revised due to suspected early poly wear.The patient was revised to an active-e poly.The event is not related to a breakage of the device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4, (b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t, (b)(6), 13a2101 - cemex system fast genta 70g, (b)(6), 200-02-35 - three peg patella 35mm, (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6), 201-78-89 - 3" drill bit, mod.Hex 2 pack, (b)(6), 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of insert prosthesis wear.Possible causes of the observed polyethylene wear include high contact stress during knee flexion, third body wear, inclusion of polyethylene in the packaging recall or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19740950
• Report Number: 1038671-2024-02388
• Device Sequence Number: 20777481
• Product Code: JWH
• UDI-Device Identifier: 10885862001887
• UDI-Public: 10885862001887
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/20/2025

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: 05/01/2023
• Device Catalogue Number: 02-012-35-4009
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2015
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male