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

Catalog Number	02-012-44-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 7292934 - 200-02-29 - three peg patella 29mm.
Event or Problem Description
As reported, the patient had an initial left tka in (b)(6)2022.In light of unforeseen complications associated with the knee prosthesis, the surgeon deemed it necessary to perform revision surgery on (b)(6)-2023.It was identified that there was mobilization of the tibia, accompanied by abnormal wear of the polyethylene component.The patient underwent a total knee revision and a non-exactech prosthesis was implanted.There was no reported breakage of a device or surgical delay/prolongation.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear and an insufficient bond between the tibial tray and the bone, which led to aseptic (non-infected) tibial loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and tibial loosening could not be determined as the devices were not returned for evaluation, and images were not provided.Section h11: the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable; 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d4: udi #.The following sections were corrected: g2, h6 clinical code, component code, investigation findings, and investigation conclusions.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18671075
• Report Number: 1038671-2024-00181
• Device Sequence Number: 12561520
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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 Catalogue Number: 02-012-44-2011
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/11/2024; 05/20/2025
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/23/2024; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female