MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM; SEE H10

Catalog Number	02-012-44-5013
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Insufficient Information (4580)
Date of Event	07/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Health effect - impact code-patient is not revised and no clinical information is provided.H6.Investigation results-the logic device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2015.There is no other patient demographic or medical history available.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5, h6-3190, 4580, 4650 codes updated.A review of manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
Plaintiff has suffered the following injuries and complications as a result of this implanted device: pain and premature arthritis.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17500175
• Report Number: 1038671-2023-01927
• Device Sequence Number: 2544033
• Product Code: JWH
• UDI-Device Identifier: 10885862173737
• UDI-Public: 10885862173737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2020
• Device Catalogue Number: 02-012-44-5013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 08/19/2025
• Date Device Manufactured: 10/09/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown