MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 years and 8 months post the initial right tka, the patient was revised due to suspected oxidation of the knee poly.The patient was revised to e-poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6) 02-010-01-0320 - logic femoral ps cem right sz 2.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 201-78-89 - 3" drill bit, mod.Hex 2 pack.(b)(6) 201-78-81 - 3" trocar, mod.Hex 2pk.(b)(6) 13a2101 - cemex system fast genta 70g.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3, h6 component code, type of investigation, investigation findings, investigation conclusions.The following sections were corrected: h6 clinical code.H3: the revision reported was likely the result of prosthesis wear.Possible causes of the observed polyethylene wear include hyperextension of the knee in-vivo, alignment of tibial construct more anteriorly with respect to the femoral component, third body wear, high contact stress during flexion, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.As the suspect device was not provided, none of these potential causes or their contribution to the sequence of events can be confirmed.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 11MM
• 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: 20332886
• Report Number: 1038671-2024-03736
• Device Sequence Number: 21230640
• Product Code: JWH
• UDI-Device Identifier: 10885862001733
• UDI-Public: 10885862001733
• 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: 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): 07/10/2025

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: 04/05/2019
• Device Catalogue Number: 02-012-35-2011
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2011
• 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: 69 YR
• Patient Sex: Female