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

Catalog Number	02-012-45-2020
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Joint Laxity (4526); Metal Related Pathology (4530); Joint effusion (4849)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 years and 8 months post the initial left total knee arthroplasty, the patient was revised due to mechanical instability and particle disease associated with pet wear.The patient was experiencing constant pain.Reported pain in relation to the tibia radiating to the pre-tibial region.Feeling of instability without falling to the ground.Increasingly reports pain and instability.Physical examination noted a cold knee, intact skin, marked pain over the tibial component and lateral tibial plateau, medial laxity with ligamentous endpoint, and non-tense joint effusion.Radiographs demonstrated osteolysis of the medial tibial plateau and medial femoral condyle.Ct findings noted cystic lesions involving both tibial plateaus and the tibial keel with evidence of polyethylene wear.Intraoperative findings include metallosis infiltration of quadriceps and patellar tendons, synovial hypertrophy with foreign-body granulomatous tissue, polyethylene debris within joint effusion, wear and partial fracture of the medial polyethylene insert, free polyethylene fragments, contained lateral femoral condyle defect (aori 2b), contained lateral tibial plateau defect (aori 2b), and mediolateral instability and positive anterior drawer test.The patient was revised with competitor prosthesis, tibial and femoral sleeves, and short uncemented tibial and femoral stems.Four intraoperative cultures were obtained; all negative.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 2F / 2T
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 352 377-1140
• MDR Report Key: 25871599
• Report Number: 1038671-2026-00917
• Device Sequence Number: 8037125
• Product Code: JWH
• UDI-Device Identifier: 10885862003904
• UDI-Public: 10885862003904
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

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: 02-012-45-2020
• 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: 07/06/2026
• Initial Report FDA Received Date: 07/20/2026
• Date Device Manufactured: 04/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG