MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 5F / 4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-5040
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient who is 10 years post right total knee replacement.Over the past several months he is developing increasing pain and swelling.His x-rays showed osteolysis under the tibial plateau without any other obvious signs of loosening in the femur or patella.There did appear to be moderate wear in the polyethylene liner.Due to the patient¿s increasing pain and debilitation, along with the x-ray showing signs of osteolysis, they were determined to be a candidate for right total knee revision.Intraoperative findings revealed significant wear of the medial aspect of the poly liner with some pitting posterior medially.The tibial component was not obviously loose but was easily removed.There were also significant osteolytic lesions primarily laterally which were contained and did not significantly affect the supportive nature of the bone.The femoral component was well fixed but was revised to allow for constrained condylar implant.The patellar component was well fixed and left in place.The patient was taken to the recovery room in satisfactory condition.There were no complications.
Additional Manufacturer Narrative
Recall number z-0021-2022.Concomitants: (b)(6) 02-010-01-0350 - logic femoral ps cem right sz 5.(b)(6) 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.(b)(6) 200-02-38 - three peg patella 38mm.(b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6) 204-70-00 - tibial stem ext.Screw.The revision reported was likely the result of tibial insert prosthesis wear over the course of 10 years.Possible causes for polyethylene wear include the alleged joint instability, high contract stresses during knee flexion, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or have occurred as a result of insert wear over time, however, the presence of joint instability cannot be confirmed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 5F / 4T
• 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
• MDR Report Key: 22814144
• Report Number: 1038671-2025-02761
• Device Sequence Number: 5714933
• Product Code: JWH
• UDI-Device Identifier: 10885862004048
• UDI-Public: 10885862004048
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 10/20/2021
• Device Catalogue Number: 02-012-45-5040
• 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: 03/17/2024
• Initial Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 10/21/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male