MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent a left knee revision due to abnormal wear of the poly.Initial implant date unknown.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: logic femoral ps cem left sz 3.5 02-010-01-0235 - 4675475 lgc tibial fit tray cem sz 3.5f/3.5t 02-012-45-3535 - 4596651 three peg patella 32mm 200-02-32 - 4779537.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6.H3: the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include high contract stresses during knee flexion, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall with the insert being packaged for over five years prior to implantation, 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 3.5 13MM
• 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: 20134075
• Report Number: 1038671-2024-03254
• Device Sequence Number: 15259309
• Product Code: JWH
• UDI-Device Identifier: 10885862001863
• UDI-Public: 10885862001863
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/07/2025

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: 03/02/2019
• Device Catalogue Number: 02-012-35-3513
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2011
• 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: Male