MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-2515
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported was likely caused by an insufficient bond between the components and the bones, which led to aseptic (non-infected) femoral and tibial loosening.Failure of the cement used to secure the femoral component and tibial tray to their respective bone, may have led to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed as the devices were not returned for evaluation.
Event or Problem Description
As reported, approximately nine years post the initial right total knee arthroplasty, the patient was brought back for right knee pain.The poly insert was removed with the help of an osteotome.The tibia was checked and found to be loose and removed.The femur was checked and found to be loose and removed.The patient was revised to a knee size 2 truliant logic cc femur, press fit stems, size 1 tibia and a 17 cc insert.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T
• 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: 22160867
• Report Number: 1038671-2025-02248
• Device Sequence Number: 15664009
• Product Code: JWH
• UDI-Device Identifier: 10885862003928
• UDI-Public: 10885862003928
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 06/06/2025

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: 08/19/2024
• Device Catalogue Number: 02-012-45-2515
• 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: 01/22/2024
• Initial Report FDA Received Date: 06/06/2025
• Date Device Manufactured: 08/21/2014
• 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: (B)(6) 200-02-32 - THREE PEG PATELLA 32MM.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female