MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 9 years and 6 months post the initial left total knee arthroplasty, the patient complained of pain and was revised due to poly wear of the insert.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
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6) 02-010-01-0235 - logic femoral ps cem left sz 3.5.(b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.(b)(6) 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h4, h6.No device was returned for evaluation; pre-revision radiographs and images of the explanted tibial insert were provided.The review noted wear and pitting of the articular surface of the explanted tibial insert, in addition to wear of the anterior and posterior aspect of the spine.The posterior wear of the tibial insert spine likely occurred from contacting the femoral component cam during deep flexion, while the anterior wear of the tibial insert spine was likely caused from contacting the femoral cam in extension.This wear to the spine may have occurred due to bone cement overhanging from the femoral implant.However, this cannot be confirmed as images of the femoral component were not provided.The provided pre-revision radiographs appear unremarkable with respect to wear or implant malaligment.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of prosthesis wear and inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene damage include high contact stresses during knee flexion and extension, inclusion of the 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 3.5 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: 23082962
• Report Number: 1038671-2025-02938
• Device Sequence Number: 17330593
• Product Code: JWH
• UDI-Device Identifier: 10885862001856
• UDI-Public: 10885862001856
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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): 09/22/2025

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: 03/01/2021
• Device Catalogue Number: 02-012-35-3511
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male