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

Catalog Number	02-012-45-4040
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-010-03-0240 - logic cr femoral cem, left, sz 4.(b)(6), 02-012-49-4013 - logic cr tib insert slope++, sz 4, 13mm.(b)(6), 200-02-32 - three peg patella 32mm.The reason for the revision was likely the result of the reported pain, which was caused by prosthesis wear or an insufficient bond between the femoral and tibial components and the bone, which led to aseptic (non-infected) loosening.The reason for the reported loosening cannot be confirmed as the devices were not returned for evaluation.Failure of the cement used to secure the femoral and tibial components to their respective bones, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.If any further information is obtained that would change or alter any.
Event or Problem Description
It was reported that approximately 57 months after a total knee replacement procedure, the patient underwent a revision procedure to address loosening, instability, joint laxity, pain, and swelling/edema.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 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: 21872613
• Report Number: 1038671-2025-01856
• Device Sequence Number: 21024970
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 04/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-45-4040
• 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: 02/14/2024
• Initial Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 03/19/2019
• 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: Disability; Required Intervention
• Patient Sex: Male
• Patient Weight: 88 KG