MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 2F / 1T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-2010
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 11 months and 29 days post the initial left total knee arthroplasty, in light of unforeseen complications associated with the knee prosthesis, the surgeon deemed it necessary to perform revision surgery.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 competitor's prosthesis was implanted.There was no reported breakage of a device or surgical delay/prolongation.
Additional Manufacturer Narrative
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.D10: (b)(6) - 200-02-29 - three peg patella 29mm.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 2F / 1T
• 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: 22062334
• Report Number: 1038671-2025-02109
• Device Sequence Number: 20742918
• Product Code: JWH
• UDI-Device Identifier: 10885862003898
• UDI-Public: 10885862003898
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 02-012-45-2010
• 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: 01/23/2024
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 10/05/2018
• 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: 63 YR
• Patient Sex: Female